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Summary Introduction Refeeding syndrome occurs with the reintroduction of food after an individual has undergone a substantial period of malnutrition. The development of this condition is not uncommon but is neglected in most cases. Objective To identify the incidence of refeeding syndrome in hospitalized patients undergoing total parenteral nutrition and factors that may be associated with this condition. Materials and methods Observational retrospective and prospective cohort study. Data collection took place at the Hospital de Clinicas de Porto Alegre, from 2015 to 2018. Data was collected consecutively from patient electronic medical records. All hospitalized individuals aged 18 years or more and having a prescription for total parenteral nutrition were included in the study. Exclusion criteria included patients with diabetic ketoacidosis; receiving renal replacement therapy or chronic kidney disease with a glomerular filtration rate Results Data from 97 patients was collected. The incidence of refeeding syndrome in our sample was 43.3% (n = 42). Factors positively associated with the syndrome were use of standard parenteral nutrition (p Conclusion The incidence of refeeding syndrome in individuals using total parenteral nutrition was high. The supply of a greater quantity of total energy in the first week of nutritional therapy, the absence of electrolytes in the parenteral nutrition solution and advancing age were all factors associated with the emergence of refeeding syndrome.

OBJECTIVES To evaluate the role of Helicobacter pylori and other risk factors in recurrent aphthous stomatitis (RAS). METHODS Patients with functional dyspepsia responded to questionnaires regarding demographic and clinical data, anxiety and depression, and a specific RAS questionnaire. They underwent upper digestive endoscopy and H. pylori evaluation. RESULTS 476 patients were included and of the 372 evaluated for H. pylori, 65.6% were H. pylori-positive. RAS was reported by 32.6% (155/476). In the bivariate analysis of the 372 patients evaluated for gastric H. pylori status, positive subjects had a lower RAS prevalence (29.9%; 73/244) than H. pylori-negative (41.4%; 53/128) (p = .026). Smoking (p = .005) and older age (p = .034) were also associated with a lower prevalence, while female gender (p = .032) and lower income (p = .046) presented higher RAS prevalence. In the multivariate analysis, H. pylori infection (p = .017), smoking (p = .001), and older age (p = .013) were protective factors, while lower income (p = .030) and anxiety (p = .042) were risk factors. In the multivariate analysis of all patients, female gender, lower income, and more schooling years were risk factors. CONCLUSIONS An unexpected lower prevalence of RAS was found in H. pylori-positive patients. Smoking, sex, age, income, education, and anxiety were associated with RAS.

Summary Background In the absence of a licensed vaccine, Clostridioides (formerly Clostridium) difficile infection represents a substantial health burden. The aim of this study was to evaluate the efficacy, immunogenicity, and safety of a toxoid vaccine candidate. Methods We did a phase 3 multicentre, observer-blind, randomised, controlled trial at 326 hospitals, clinics, and clinical research centres in 27 countries in the USA, Canada, Latin America, Europe, and the Asia-Pacific region. We included adults aged 50 years or older who were considered to be at an increased risk of C difficile infection because they had previously had two hospital stays (each ≥24 h in duration) and had received systemic antibiotics in the previous 12 months (risk stratum 1), or because they were anticipating being admitted to hospital for 72 h or more for elective surgery within 60 days of enrolment (risk stratum 2). Eligible participants were stratified by geographical region and the two risk strata, and randomly assigned (2:1), with a fixed block size of three, to receive either a C difficile toxoid vaccine candidate, containing toxoids A and B (C difficile vaccine candidate group), or a placebo vaccine (placebo group). Participants, investigators, and personnel responsible for collecting safety data and analysing blood and stool samples were masked to group assignment. Personnel responsible for study product preparation and administration were not masked to group assignment. One dose (0·5 mL) of C difficile vaccine candidate or placebo vaccine was administered intramuscularly on days 0, 7, and 30. The primary outcome was the efficacy of the vaccine in preventing symptomatic C difficile infection, defined as having three or more loose stools in a period of 24 h or less, loose stools for 24 h or more, and a PCR-positive test for C difficile toxin B in a loose stool sample, within 3 years after the final vaccine dose. The primary outcome was measured in the modified intention-to-treat population (ie, all participants who received at least one injection of the assigned vaccine). The safety of the vaccine was assessed in the safety analysis set (ie, all participants who had received at least one injection, analysed according to the product received). This study is registered with WHO/ICTRP, number U111-1127-7162, and ClinicalTrials.gov , number NCT01887912 , and has been terminated. Findings Between July 30, 2013, and Nov 17, 2017, we enrolled and randomly assigned 9302 participants to the C difficile vaccine candidate group (n=6201) or to the placebo group (n=3101). 6173 (99·5%) participants in the C difficile vaccine candidate group and 3085 (99·5%) participants in the placebo group received at least one dose of the vaccine. The study was terminated after the first planned interim analysis because of futility. In the C difficile vaccine candidate group, 34 C difficile infections were reported over 11 697·2 person-years at risk (0·29 infections per 100 person-years [95% CI 0·20–0·41]) compared with 16 C difficile infections over 5789·4 person-years at risk in the placebo group (0·28 infections per 100 person-years [0·16–0·45]), indicating a vaccine efficacy of −5·2% (95% CI −104·1 to 43·5). In the C difficile vaccine candidate group, 2847 (46·6%) of 6113 participants reported an adverse event within 30 days of injection compared with 1282 (41·9%) of 3057 participants in the placebo group. The proportion of participants who had an adverse event leading to study discontinuation was 4·8% in both groups (296 participants in the C difficile vaccine candidate group and 146 participants in the placebo group). 1662 (27·2%) participants in the C difficile vaccine candidate group reported at least one serious adverse event compared with 851 (27·8%) participants in the placebo group. Interpretation In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection. Since the C difficile vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped. Funding Sanofi Pasteur.

Summary Background Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who had been previously treated with anti-tumour necrosis factor (TNF) agents. Methods HICKORY was a multicentre, phase 3, double-blind, placebo-controlled study in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) previously treated with TNF inhibitors. Patients were recruited from 184 treatment centres across 24 countries in North America, South America, Europe, Asia, Oceania, and the Middle East. Patients needed to have an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In cohort 1, patients received open-label etrolizumab 105 mg every 4 weeks for a 14-week induction period. In cohort 2, patients were randomly assigned (4:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks for the 14-week induction phase. Patients in either cohort achieving clinical response to etrolizumab induction were eligible for the maintenance phase, in which they were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks through to week 66. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants (induction randomisation only), baseline disease activity, week 14 MCS remission status (maintenance randomisation only), and induction cohort (maintenance randomisation only). All patients and study site personnel were masked to treatment assignment. Primary endpoints were remission (Mayo Clinic total score [MCS] ≤2, with individual subscores of ≤1 and a rectal bleeding subscore of 0) at week 14, and remission at week 66 among patients with a clinical response (MCS with ≥3-point decrease and ≥30% reduction from baseline, plus ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) at week 14. Efficacy was analysed using a modified intent-to-treat population. Safety analyses included all patients who received at least one dose of study drug during the induction phase. This study is registered at ClinicalTrials.gov , NCT02100696 . Findings HICKORY was conducted from May 21, 2014, to April 16, 2020, during which time 1081 patients were screened, and 609 deemed eligible for inclusion. 130 patients were included in cohort 1. In cohort 2,479 patients were randomly assigned to the induction phase (etrolizumab n=384, placebo n=95). 232 patients were randomly assigned to the maintenance phase (etrolizumab to etrolizumab n=117, etrolizumab to placebo n=115). At week 14, 71 (18·5%) of 384 patients in the etrolizumab group and six (6·3%) of 95 patients in the placebo group achieved the primary induction endpoint of remission (p=0·0033). No significant difference between etrolizumab and placebo was observed for the primary maintenance endpoint of remission at week 66 among patients with a clinical response at week 14 (27 [24·1%] of 112 vs 23 [20·2%] of 114; p=0·50). Four patients in the etrolizumab group reported treatment-related adverse events leading to treatment discontinuation. The proportion of patients reporting at least adverse event was similar between treatment groups for induction (etrolizumab 253 [66%] of 384; placebo 63 [66%] of 95) and maintenance (etrolizumab to etrolizumab 98 [88%] of 112; etrolizumab to placebo 97 [85%] of 114). The most common adverse event in both groups was ulcerative colitis flare. Most adverse events were mild or moderate. During induction, the most common serious adverse event was ulcerative colitis flare (etrolizumab ten [3%] of 384; placebo: two [2%] of 95). During maintenance, the most common serious adverse event in the etrolizumab to etrolizumab group was appendicitis (two [2%] of 112) and the most common serious adverse events in the etrolizumab to placebo group were ulcerative colitis flare (two [2%] of 114) and anaemia (two [2%] of 114). Interpretation HICKORY demonstrated that a significantly higher proportion of patients with moderately to severely active ulcerative colitis who had been previously treated with anti-TNF agent were able to achieve remission at week 14 when treated with etrolizumab compared with placebo; however, there was no significant difference between groups in remission at week 66 among patients with a clinical response at week 14. Funding F Hoffmann-La Roche.

The present study aimed to evaluate the influence of the IL1B -31C/T polymorphism on gastric inflammatory response and precancerous lesions development – atrophic gastritis (AG) and intestinal metaplasia (IM) – in patients positive for Helicobacter pylori infection with functional dyspepsia (FD). The diagnosis of FD followed the Rome III criteria, and the H. pylori infection was evaluated by urease test and histological examination of gastric biopsies (corpus, antrum, and incisura). The severity of chronic inflammation and inflammatory activity, as well as the presence of precancerous lesions were evaluated accordingly to the updated Sydney System. Genotyping of the IL1B -31C/T polymorphism (rs1143627) was performed by polymerase chain reaction-restriction fragment length polymorphism. A total of 303 patients positive for H. pylori infection with FD were analyzed (81.8% women; mean age of 46.3 ± 12.3 years). No differences were observed in overall genotype frequencies among outcomes evaluated. However, in the dominant -31C allele model (CC+CT vs. TT), the frequency of the TT genotype was significantly higher among patients with moderate/severe chronic inflammation of the antrum than the frequency of the CC+CT genotypes (80.8% vs. 65.2%; OR = 2.25; 95% CI = 1.23-4.24; P = .005). The presence of AG and IM in the gastric mucosa of patients was of 19.5% and 19.1%, respectively. No significant association was observed concerning the frequencies of the genotypes of IL1B -31C/T polymorphism with development of precancerous lesions. In conclusion, our data suggest that genetic variants of the IL1B -31C/T polymorphism play a role in chronic inflammation of the gastric mucosa in H. pylori-infected FD patients.

BACKGROUND: Inflammatory bowel disease frequently affects patients at working age, compromising their quality of life in several levels: physical, psychological, familial and social. Few studies have evaluated the impact of Inflammatory bowel disease on quality of life, anxiety and depression in Brazilian patients. OBJECTIVE: Evaluate quality of life and its correlation with psychological aspects of patients with inflammatory bowel disease through the Inflammatory Bowel Disease Questionnaire and Hospital Anxiety and Depression Scale. METHODS: Cross-sectional study; Inflammatory Bowel Disease Questionnaire, Short Form-36 and Hospital Anxiety and Depression Scale were applied to consecutive outpatients in a tertiary referral center for inflammatory bowel disease. Harvey-Bradshaw Index and Truelove scores were used to evaluate Crohn’s disease and ulcerative colitis activity. Sample calculation: 113 patients for a significance level of 5%, power of 90% and a correlation coefficient of at least 0.3 between scales. Statistical analysis: Student-t test, Pearson and Spearman correlations. RESULTS: One hundred twenty patients participated in the study; mean age: 41.7 years; female: 58.3%; Crohn’s Disease: 69 patients. No low scores for quality of life were found across the four Inflammatory Bowel Disease Questionnaire domains; the Short Form-36 showed low scores in physical limitations (47.2±42.4) and emotional aspects (49.8±43.4); Hospital Anxiety and Depression Scale score presented a mean of 9.5±2.7 for anxiety and 8.7±2.0 for depression. Quality of life was decreased and Hospital Anxiety and Depression Scale did show increased indices of anxiety and depression, in both diseases only when clinically active. CONCLUSION: Inflammatory Bowel Disease Questionnaire and Hospital Anxiety and Depression Scale showed that outpatients of a tertiary care center for inflammatory bowel disease in Brazil presented good quality of life. The worst quality of life was associated with the intensity of the disease activity.

Aim: To analyze the influence of the –31 C/T polymorphism of the interleukin-1β gene on Helicobacter pylori eradication therapy success in patients with functional dyspepsia. Methods: Functional dyspepsia was diagnosed according to the Rome III criteria. All patients underwent upper gastrointestinal endoscopy, and gastric biopsies were obtained at screening and 12 months after randomization (last follow-up visit). Urease test and histological examination were performed to define the H. pylori status. Patients received twice-daily amoxicillin, clarithromycin and omeprazole for 10 days. Genotyping of the interleukin-1beta –31 C/T polymorphism (rs1143627) was performed using polymerase chain reaction-restriction fragment length polymorphism. Results: One hundred forty-nine patients received treatment with triple therapy for H. pylori eradication. Only one patient was lost to follow-up, and adherence to study medication was 94.6%. A total of 148 patients (mean age 46.08 ± 12.24 years; 81.8% women) were evaluated for the influence of the interleukin-1beta –31 C/T polymorphism on the outcome of H. pylori eradication therapy. After treatment, bacteria were eradicated in 87% of patients (129/148). Genotype frequencies of the polymorphism were as follows: CC, 38/148 (25.7%); CT, 71/148 (47.9%); and TT, 39/148 (26.4%). Successful eradication rate was 78.9%, 94.4% and 82.1% for the CC, CT and TT genotypes, respectively. The CT genotype was significantly associated with successful H. pylori eradication (p = 0.039). Conclusion: This study suggests that the CT genotype of the interleukin-1beta –31 C/T polymorphism plays a role in the successful eradication of H. pylori among patients with functional dyspepsia. Keywords: Helicobacter pylori, Dyspepsia, Interleukin-1beta, Polymorphism, Inflammation

Functional dyspepsia and lactose intolerance (adult-type hypolactasia, ATH) are common conditions that may coexist or even be confounded. Their clinical presentation can be similar, however, lactose intolerance does not form part of the diagnostic investigation of functional dyspepsia. Studies on the association between functional dyspepsia and ATH are scarce. This study aimed to evaluate whether ATH is associated with symptoms of functional dyspepsia. Patients fulfilling the Rome III diagnostic criteria for functional dyspepsia underwent genetic testing for ATH. Dyspeptic symptoms were evaluated and scored according to a validated questionnaire. The diagnostic criteria for ATH was a CC genotype for the -13910C/T polymorphism, located upstream of the lactase gene. The mean scores for dyspeptic symptoms were compared between patients with ATH and those with lactase persistence. A total of 197 functional dyspeptic patients were included in the study. Mean age was 47.7 years and 82.7% patients were women. Eighty-eight patients (44.7%) had a diagnosis of ATH. Abdominal bloating scores were higher in ATH patients compared to the lactase persistent patients (P=0.014). The remaining dyspeptic symptom scores were not significantly different between the two groups. The study results demonstrate an association between ATH and bloating in patients with functional dyspepsia.

The phenotypic expression of Crohn’s disease may vary over time. Establishment of Crohn’s disease phenotypes is important for definition of patient care strategies. The aim of the study was to evaluate the long-term evolution of patients based on disease phenotypes and the main factors associated with this evolution. Data from 179 patients were collected from a unicentric prospective database. Montreal classification was employed. Kaplan–Meier method was used to estimate the cumulative probability of complication development and surgery. Poisson regression for multivariate analysis was applied. The Local Institutional Review Board approved the research. Female: 54.2%. Mean age at diagnosis: 32.7 (±13.7) years. Behavior at presentation: inflammatory 62.0%, stricturing 24.6%, penetrating 13.4%; perianal disease: 31.8%; median follow-up time: 65.2 months (IQR 31.0–108.8). Behavior at follow-up period end: inflammatory 43.6%, stricturing 38.0%, penetrating 18.4%; perianal disease: 46.4%. Cumulative probability of being complication free in 5, 10, and 20 years: 86.3, 66.4, and 52.2%, respectively. Cumulative probability of being surgery free in 5, 10, and 20 years: 87.3, 79.2, and 64.1%, respectively. L1 and L4 locations, use of immunosuppressive therapy, smoking, number of hospitalization/patient-year, abdominal surgery, age at diagnosis

The aim of this study was to examine the effect of polymorphisms in the cytochrome P450 (CYP) 2C19 gene (CYP2C19) on the Helicobacter pylori eradication rate in Brazilian patients with functional dyspepsia. Adults diagnosed with functional dyspepsia based on the ROME III criteria and infected with H. pylori were recruited to this study. The patients were subjected to gastrointestinal endoscopy and the H. pylori status was defined when both urease test and histopathology results were negative or positive. The patients were treated with proton pump inhibitor-based triple therapy (omeprazole, amoxicillin, and clarithromycin). CYP2C19*2 and CYP2C19*3 were genotyped by polymerase chain reaction-restriction fragment length polymorphism. One hundred and forty-eight patients (81.8% women) with a mean (± SD) age of 46.1 (12.2) years were included in this study. Based on the CYP2C19 genotypes, the patients were classified as homozygous extensive metabolizer (HomEM; 67.6%), heterozygous extensive metabolizer (HetEM; 26.3%), or poor metabolizer (PM; 6.1%). The H. pylori eradication rates in patients with HomEM, HetEM, and PM were 85.0, 89.7, and 100.0% (P = 0.376), respectively. The included study population comprised a high frequency of patients carrying the HomEM genotype. Although the genotypes of CYP2C19 variants were not statistically significant, the results of this study suggest a possible effect of the PM genotype on the efficacy of H. pylori eradication.

Contexto - A hipolactasia primária é uma condição muito frequente na qual há redução da atividade da lactase na mucosa intestinal. A presença de sintomas abdominais devidos à má absorção da lactose presente em alguns casos caracteriza a intolerância à lactose. Objetivo - Avaliar a eficácia de um produto contendo lactase exógena em comprimidos comparativamente a de um produto comparador com eficácia comprovada em pacientes portadores de intolerância à lactose. Métodos - Estudo multicêntrico, randomizado, de grupos paralelos, com investigador cego, comparativo de não-inferioridade. Cento e vinte e nove (129) pacientes adultos portadores de intolerância à lactose e teste do hidrogênio no ar expirado compatível com o diagnóstico de hipolactasia foram randomizados para receber o produto experimental (Perlatte® - Eurofarma Laboratórios S.A.) ou o produto comparador (Lactaid® - McNeil Nutritionals, EUA), por via oral (um comprimido, três vezes ao dia), durante 42 dias consecutivos. Resultados - Os dados dos 128 pacientes que efetivamente receberam o tratamento do estudo foram avaliados (66 tratados com o produto experimental e 62 com o produto comparador). Os dois grupos se mostraram homogêneos quanto aos dados demográficos e clínicos basais. A média da concentração do hidrogênio expirado aos 90 minutos no teste realizado ao final do tratamento (Dia 42) foi significativamente menor no grupo tratado com o produto experimental (17±18 ppm versus 34±47 ppm na população por protocolo). A diferença entre as médias dos dois grupos foi de -17 ppm (intervalo de confiança de 95% [IC95%]: -31,03; -3,17). O limite superior do IC95% não ultrapassou a margem de não-inferioridade estipulada a priori (7,5 ppm). As análises secundárias de eficácia confirmaram a semelhança entre os tratamentos (populações por protocolo e com intenção de tratamento). Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance. Objective - Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance. Methods - Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte ® - Eurofarma Laboratórios S.A.) or the reference product (Lactaid® - McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days. Results - Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment. A tolerabilidade foi excelente em ambos os grupos e não houve relato de eventos adversos graves relacionados ao produto. Conclusão - O produto experimental se mostrou não-inferior ao produto comparador, indicando sua eficácia no tratamento substitutivo da lactase endógena em pacientes portadores de intolerância à lactose.

Background and Aims: The histopathological discrimination of Crohn’s disease [CD] and ulcerative colitis [UC] can be challenging. The aim of this study was to evaluate if quantification of CD30+ lymphocytes and eosinophils in histopathological material improves the accuracy of diagnosis of inflammatory bowel disease. Methods: A total of 156 patients were diagnosed with IBD by a gastroenterologist and corroborated by 5 years of follow-up. Patients were treatment naive at the time of biopsy. Samples were taken from diseased areas of the colon and examined by a gastrointestinal pathologist. Results: The median number of eosinophils in biopsies from affected segments was 42/high power field \[hpf\] \[25.5–63.5\] in CD and 98/hpf [67–123] in UC [ p < 0.001]. Biopsies containing ≥ 70 eosinophils/hpf field had a sensitivity of 78.3% and a specificity of 71% for the diagnosis of UC ({area under the receiver operating characteristic (ROC) curve 0.767 (95% confidence interval [CI] 0.696–0.838)}. There was a median of three CD30+ cells/hpf [range 2–6] in diseased CD biopsies and 33 cells/hpf [24–52] in diseased UC biopsies [ p < 0.001]. The cut-off determined by the ROC curve was 15 (sensitivity 97.4%, specificity 97.4%, positive likelihood ratio (PLR) 17.1, Negative likelihood ratio (NLR) 0.03, area under the curve [AUC]: 0.978; 95% CI 0.95310.999). Conclusions: Routine histopathological assessment with quantification of CD30+ cells is highly accurate at discriminating CD and UC. All the measured parameters are easy to perform, low-cost, and available in most pathological laboratories.

Ninety-one Helicobacter pylori-positive patients with nonulcer dyspepsia were randomized to receive either lansoprazole, amoxicillin, and clarithromycin or lansoprazole and placebo. A validated questionnaire assessed dyspeptic symptoms at baseline and at 3, 6, and 12 months. Endoscopies and biopsies were performed at baseline and at 3 and 12 months. There was an overall trend, although not statistically significant, for a benefit of H. pylori eradication. Of the patients in the antibiotics group, 16 of 46 (35%) had symptomatic improvement, versus 9 of 43 (21%) in the control group (P = 0.164). In a secondary analysis, it was found that of the patients without endoscopic gastric erosions, 15 of 34 (44%) in the antibiotics group and 5 of 33 (15%) of controls had symptomatic improvement (P = 0.015). Helicobacter pylori eradication did not prove to be clinically beneficial, although a tendency to symptomatic benefit was detected. Further studies are necessary to confirm the implications of endoscopic gastric erosions in these patients.

Despite its high prevalence, nonulcer dyspepsia is still difficult to study, due to the lack of adequate tools to measure significant outcomes. The objective of this study was to develop and validate a symptom-focused, disease-specific questionnaire to evaluate patients with nonulcer dyspepsia. For that, the questionnaire was carefully written following widely accepted terminology, so as to facilitate translation and validation in other languages and cultures. The questionnaire was developed using Rome I terminology for symptoms, which were evaluated according to their intensity, duration, and frequency when applicable. Thirty-one patients with nonulcer dyspepsia, as well as 31 sex-and age-matched volunteers without digestive problems were used to assess the internal consistency, reproducibility, responsiveness, content validity, and discriminant validity of the questionnaire. Another 31 functional dyspeptic patients were enrolled for assessment of criterion validity. Cronbach's alpha coefficient was 0.82. The intraclass correlation coefficient for the scores obtained 7 days apart was 0.86. The mean score obtained after 3 months of treatment was 16.4, vs. 23.03 at baseline (P = 0.001). Two blinded gastroenterologists agreed that the questionnaire adequately evaluated nonulcer dyspepsia. The median symptoms score for controls was 0, vs. 22.5 for dyspeptic patients (P = 0.001). An inverse correlation was observed between quality of life and dyspeptic symptoms (R = -0.28, P = 0.026). The proposed questionnaire has high degrees of both reproducibility and responsiveness. As this questionnaire was based on Rome I International Consensus terminology, it is expected that it will be easy to translate and validate.

Introduction Crohn’s disease (CD) may lead to protein and calorie malnutrition (PCM) secondary to impaired digestive and absorptive functions of the small intestine and sometimes to the influence of diet taboos. The earlier the PCM is diagnosed, the higher are the odds of reversal. The objective of this study was to compare different methods of nutritional assessment in patients with CD and correlate them with the disease characteristics. Sample The sample comprised 75 patients with CD from the Gastroenterology Service at the Hospital de Clinicas de Porto Alegre; 37 were male, with a mean age of 38.2 years old (SD = 13.3). All patients had been in clinical remission (CDAI

BACKGROUND: The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS: Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS: A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40) and sodium picosulfate (40). Both groups received the same dietary orientation. The study was approved by the hospital’s Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS: There were no statistically significant differences between the groups in relation to the level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5%. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80% said yes from the mannitol group and 92.5% from the sodium picosulfate group. CONCLUSION: The quality of the colon preparation, foam formation, exam duration, and the collateral effects (nauseas, vomiting, and abdominal pain) were similar in both kinds of preparations. Abdominal distension was greater in the mannitol group. Both methods of preparation were well accepted by the hospitalized patients. RACIONAL: A limpeza do cólon para o exame de colonoscopia deve ser completa de modo a permitir a visualização e inspeção do lúmen intestinal. O agente de limpeza ideal deveria ser de fácil administração, com baixo custo e com o mínimo de efeitos colaterais. O picosulfato de sódio juntamente com o citrato de magnésio é um estimulante catártico e o manitol é um laxativo osmótico, ambos geralmente utilizados para este propósito. OBJETIVOS: Verificar a limpeza do cólon comparando o uso de manitol e picosulfato de sódio assim como avaliar o nível de satisfação do paciente, presença de espuma, dor e distensão abdominal em pacientes hospitalizados submetidos a colonoscopia. MÉTODOS: Estudo prospectivo, randomizado, simples-cego com 80 pacientes que comparou dois grupos: manitol (40) e picosulfato de sódio (40). Ambos os grupos receberam a mesma orientação dietética. O estudo foi aprovado pelo Comitê de Ética do hospital e pelo Comitê de Pesquisa. O endoscopista foi cego para o tipo de preparo. Desfechos avaliados: nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor e distensão abdominal e tempo de duração do exame. Os dados foram analisados pelas médias de testes qui-quadrado para proporções e Mann-Whitney para amostras independentes. RESULTADOS: Não houve diferença significativa entre os grupos em relação ao nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor abdominal e tempo de exame. Quinze porcento dos exames do grupo manitol foram interrompidos enquanto que grupo picosulfato de sódio foi de 5%. A presença de espuma foi similar em ambos os grupos. A média de duração do exame foi de 28h 44min para o grupo manitol e 35h 59min para o grupo picosulfato de sódio. A distensão abdominal foi mais freqüente no grupo manitol. Se eles tivessem que repetir o exame, a resposta foi de 80% disse sim do grupo manitol e 92,5% do grupo picosulfato de sódio. CONCLUSÕES: A qualidade do preparo de cólon, formação de espuma, tempo de exame, efeitos colaterais (náuseas, vômitos e dor abdominal) foi similar em ambos os tipos de preparo. A distensão abdominal foi maior no grupo manitol. Ambos os métodos de preparo foram bem aceitos pelos pacientes hospitalizados.

Summary Background : The protective role of Helicobacter pylori in gastro-oesophageal reflux disease has been widely discussed. Aim : To assess the risk of reflux oesophagitis in patients with functional dyspepsia after treatment for H. pylori infection. Methods : A randomized, placebo-controlled, investigator-blinded trial was carried out on 157 functional dyspeptic patients. Patients were randomized to receive lansoprazole, amoxicillin and clarithromycin (antibiotic group) or lansoprazole and identical antibiotic placebos (control group). Upper gastrointestinal endoscopy was performed at baseline, 3 and 12 months after randomization. The primary aim was to detect the presence of reflux oesophagitis. Analyses were performed on an intention-to-treat basis. Results : A total of 147 patients (94%) and 133 (85%) completed 3 months and 12 months follow-up, respectively. The eradication rate of H. pylori was 90% in the antibiotic group (74 of 82) and 1% (one of 75) in the control group. At 3 months, reflux oesophagitis was diagnosed in 3.7% (three of 82) in the antibiotic group and 4% (three of 75) in the control group (P > 0.2). At 12 months, diagnosis was established in five new cases within the first group and in four within the second (P > 0.2). No difference was found in heartburn symptoms. Conclusions : H. pylori eradication does not cause reflux oesophagitis in this western population of functional dyspeptic patients.

RACIONAL: O transplante hepático é o tratamento de escolha para várias doenças hepáticas terminais. A desnutrição nesta população é freqüente. O uso de nutrição enteral precoce não é rotina nos grupos de transplante. OBJETIVO: Relatar a experiência do uso de nutrição enteral precoce em indivíduos transplantados hepáticos e avaliar sua segurança. PACIENTES/MÉTODOS: Foram estudados 35 adultos submetidos a transplante hepático. A avaliação do estado nutricional pré-transplante hepático foi realizada pela avaliação nutricional subjetiva global e força do aperto da mão não-dominante, aferida pela dinamometria. A dieta enteral foi iniciada em até 12 horas. A via oral foi iniciada assim que houvesse ruídos hidroaéreos. RESULTADOS: A média de idade dos indivíduos avaliados foi de 45,5 anos (± 8,93). De acordo com a avaliação nutricional subjetiva global, a prevalência de desnutrição pré-transplante foi de 77,1% e pela força do aperto da mão não-dominante de 100%. A nutrição enteral precoce foi iniciada em até 12 horas, moda de 10,9 horas e mantida exclusivamente por período médio de 2,6 dias (± 2,2). Via oral exclusiva foi obtida no período médio de 9,5 dias (± 9,7). A nutrição enteral precoce proveu o aporte calórico estimado em 97% dos casos. Intolerância à dieta enteral ocorreu em cinco indivíduos (14,2%), sendo que em quatro foi reinstituída com sucesso após intervalo de 12 horas. A prevalência de infecção respiratória foi de 28,6%. Em apenas dois pacientes (5,7%) houve broncopneumonia com aspecto aspirativo ao estudo radiológico do tórax. CONCLUSÕES: A nutrição enteral precoce foi um método eficaz na provisão de calorias e seguro em sua aplicação a pacientes transplantados hepáticos. BACKGROUND: Orthotopic liver transplantation is the treatment of choice for end-stage liver disease. Malnutrition is common in this population. Early enteral nutrition is not routine in the transplant groups. AIM: To report our experience with the use of early enteral nutrition in patients undergoing orthotopic liver transplantation and also evaluate its safety. PATIENTS/METHODS: We studied 41 adults submitted to orthotopic liver transplantation. Pre- orthotopic liver transplantation nutritional assessment was accomplished by the subjective global assessment and grip strength. Enteral nutrition was begun in 12 hours. Oral feeding was initiate gradually as soon as possible. RESULTS: We studied 35 individuals, with an average of age of 45.5 years (8.93). The prevalence of malnutrition in orthotopic liver transplantation was of 77.1% determined by subjective global assessment, and 100% by grip strength. Early enteral nutrition was begun in all of the individuals in up to 12 hours, mode 10.9 hours, and maintained exclusively by medium period of 2.6 days (2.2). Oral feeding was obtained in the medium period of 9.5 days (9.7). Early enteral nutrition provided total caloric intake in 97% of the cases. Intolerance to the enteral feeding occurred in five individuals (14.2%), and in four of them it was resumed successfully after 12 hours. The prevalence of respiratory infection was of 28.6%. In only two patients (5.7%) there was aspirative bronchopneumonia. CONCLUSIONS: Early enteral nutrition is an effective method in the provision of calories and safe in application to patients undergoing orthotopic liver transplantation.

was categorized as "negative" or "positive" or "eradicated". The study patients were categorized according to the presence of inlet patch as follows: group A, inlet patch positive; group B, inlet patch negative. Intergroup male-to-female ratios, H. pylori infection rate, and the prevalence of gastrointestinal diseases were compared using the Chi square test. Result: The baseline clinical characteristics are shown in Table 1. A total of 487 patients (237 females and 250 males, mean age 53.7 years) were examined. Of these, 47 patients (9.4%) were inlet patch positive (Group A), and 440 patients were inlet patch negative (Group B). The male-to-female ratio was significantly higher in group A than group B. Mean age was not statistically different in group A and group B. The prevalence of gastric atrophy, reflux esophagitis, esophageal hiatal hernia, and Barrett's esophagus were not different in group A and group B. The 47 inlet patches were pathologically examined, and the histological features were inactive atrophic fundic mucosa with mild to moderate mucus neck cell or pyloric gland cell metaplasia and no intestinal metaplasia except one case with H. pylori infection. Conclusion: Endoscopic detection rate of inlet patch was 9.4%. Male gender was risk factor for inlet patch. Pathological characteristics of inlet patch was mostly inactive fundic gastritis with (pseudo) pyloric gland metaplasia.

was categorized as "negative" or "positive" or "eradicated". The study patients were categorized according to the presence of inlet patch as follows: group A, inlet patch positive; group B, inlet patch negative. Intergroup male-to-female ratios, H. pylori infection rate, and the prevalence of gastrointestinal diseases were compared using the Chi square test. Result: The baseline clinical characteristics are shown in Table 1. A total of 487 patients (237 females and 250 males, mean age 53.7 years) were examined. Of these, 47 patients (9.4%) were inlet patch positive (Group A), and 440 patients were inlet patch negative (Group B). The male-to-female ratio was significantly higher in group A than group B. Mean age was not statistically different in group A and group B. The prevalence of gastric atrophy, reflux esophagitis, esophageal hiatal hernia, and Barrett's esophagus were not different in group A and group B. The 47 inlet patches were pathologically examined, and the histological features were inactive atrophic fundic mucosa with mild to moderate mucus neck cell or pyloric gland cell metaplasia and no intestinal metaplasia except one case with H. pylori infection. Conclusion: Endoscopic detection rate of inlet patch was 9.4%. Male gender was risk factor for inlet patch. Pathological characteristics of inlet patch was mostly inactive fundic gastritis with (pseudo) pyloric gland metaplasia.