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Aims: During the COVID-19 pandemic, children and adolescents with a psychiatric disorder experienced exacerbation of their symptoms with more accesses in Emergency Department (ED). However, little is known about the experience of somatic symptom disorders (SSDs) during the COVID 19 pandemic in children. Therefore, we aimed to compare the rates of pediatric ED admissions for SSDs before and during COVID-19 pandemic and to understand whether the relative risk of ED admissions for SSDs changed between the two periods. Methods: We enrolled all children admitted for SSDs in pediatric ED of Santobono-Pausilipon Hospital, Naples, Italy, from March 11th, 2020 to March 11 th, 2021 (pandemic period) and in the same time period of the previous year (pre-pandemic period). Results: We identified 205/95743 (0,21%) children with SSDs presenting in ED in pre-pandemic year and 160/40165 (0,39%) in pandemic year (pConclusions: In this retrospective study we found that despite the massive decrease of the pediatric admissions due to the COVID-19 pandemic, somatic symptom disorders admissions to the pediatric ED increased ,suggesting an impact of the pandemic also on the pediatric psychiatric disorders.

BACKGROUND: Achalasia is an esophageal motility disorder characterized by esophagogastric junction (EGJ) dysfunction and impaired esophageal peristalsis with significant impact on quality of life. While the functional luminal imaging probe (FLIP) has been used to assess EGJ distensibility in achalasia, its clinical utility in pediatrics is limited due to absence of normative values and correlations with clinical outcomes in children. Thus, we sought to evaluate FLIP's use in a pediatric achalasia cohort undergoing dilations and non-achalasia controls. METHODS: We conducted a retrospective study of pediatric patients with achalasia who underwent FLIP before and immediately after balloon dilations and compared to a non-achalasia cohort. KEY RESULTS: Thirty patients with achalasia (mean age, 15.2 years; 40% female), including fourteen treatment-naïve and thirteen controls (mean age, 7.9 years; 61% female) were identified. Median EGJ distensibility index (EGJ-DI) 2.07 mm(2) mmHg(−1) and diameter (9.23 mm) in treatment-naïve patients were significantly lower compared to controls (EGJ-DI 6.8 mm(2) mmHg(−1); diameter 18.61 mm; (p < 0.001). Balloon dilations resulted in a significant increase in EGJ-DI immediately after the dilation, particularly in treatment-naïve patients (p < 0.001), and a significant improvement in Eckardt scores (p < 0.001). CONCLUSIONS & INFERENCES: Functional luminal imaging probe measurements of EGJ-DI in pediatric patients with achalasia are mostly consistent with adult findings. However, normal EGJ-DI is seen in symptomatic patients, including treatment-naive, highlighting the need for pediatric reference data. Balloon dilations achieve a significant increase in EGJ-DI with improvement in Eckardt scores, confirming the therapeutic value of dilations in achalasia management.

Background High-resolution anorectal manometry (HR-ARM) is expected to be better than conventional manometry. Our aim was to characterize HR-ARM pressures in children with functional constipation (FC), with or without fecal incontinence (FI). Methods Children with diagnosis of FC, with or without FI, according to Rome-IV criteria, were enrolled. All patients underwent HR-ARM using 24-channel water-perfused catheter. Results Twenty-nine consecutive children (M/F: 21/8; mean age ± SD: 9.5 ± 3.1 years; range 4-15), of whom 21 affected by FC without FI (mean age ± SD: 9.3 ± 3.23 years) and 8 affected by FC with FI (mean age ± SD: 10.2 ± 3.08 years), were enrolled. No significant differences were found regard to gender and age. The analysis of HR-ARM 3D plots demonstrated asymmetry of the anal canal, with higher pressures in distal halves. Comparing pressures between the two groups, we found lower values in FC with FI than in FC without FI group, with a statistically significance for maximum and mean resting pressures (P = .032 and P = .008, respectively). When evaluating our study population respect to asymptomatic children, we found lower resting pressures, lower maximum squeeze pressure, and higher rectoanal inhibitory reflex (RAIR) values. Conclusions Our data demonstrate that HR-ARM pressures at rest and during squeezing in FC with FI children are lower than FC without FI subjects, particularly in anteroposterior quadrants. Compared to children without lower gastrointestinal symptoms, children with FC with or without FI show lower pressures and higher values of RAIR.

Background Ascites can develop as a consequence of a number of diseases in childhood. Despite chronic liver disease is the most common cause, several conditions can lead to ascites also in the absence of liver dysfunction. As non-cirrhotic ascites shows a high degree of overlapping sign and symptoms it is still a challenge for physicians. Case presentation A 8-year-old Caucasian girl was referred for fever, vomit and diarrhea occurred over the past few weeks. Physical examination showed timpanitic distension of the abdomen with marked tenderness and increased abdominal wall rigidity. Abdominal imaging showed diffuse ascites and thickened omentum and bowel wall. Blood tests showed increased C- reactive protein levels and decreased lymphocyte count. Specific treatment for inflammatory bowel disease was started. Persisting of ascites required additional investigations. Positive tuberculin skin test and Interferon Gamma release assay (IGRA) as well as increased Ca125 serum concentrations were found. Computed tomography scan showed mediastinal and mesenteric adenopathies and diffuse smooth thickening of the omentum with significant enhancement (omental cake-like). Ascitic fluid analysis revealed high leucocytes and protein levels. Presumptive diagnosis of peritoneal tuberculosis (PTB) was made. Antituberculous treatment resulted in the resolution of ascites and normalization of lymphocyte count and Ca125 serum concentrations. Conclusions PTB is still possible in low-prevalence countries. As it is a great mimicker of other abdominal pathology whose treatment might worsen tuberculosis progression, clinical suspicion and adequate screening are required to avoid unnecessary interventions and delayed treatment. Ca125 is a non-specific marker of peritoneal inflammation but it might be helpful in monitoring the treatment response.

Background Despite the rising of the Functional Gastrointestinal Disorders (FGIDs)’ incidence in the last years, the etio-pathogenesis of FGIDs remains unclear. The diet seems to play an important role in these disorders. Indeed, at least two thirds of adult patients with Irritable Bowel Syndrome (IBS) and of children with FGIDs perceive their GI symptoms to be food-related. In particular, in the last years, more interest has been focused in the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyol (FODMAPs) diet. Aims To provide a systematic review on the efficacy of a low FODMAPs diet in reducing symptoms associated with functional abdominal pain disorders. Methods Cochrane Library, MEDLINE (via Pubmed), and EMBASE databases from inception to June 2017 were searched. We included randomized controlled trials (RCTs), prospective and retrospective studies, systematic reviews and meta-analyses, reporting the efficacy of the FODMAPs diet intervention in FGIDs patients. Results Nineteen studies were eligible. A FODMAPs-restricted diet is beneficial in 12/13 intervention trials. The low FODMAPs diet improves overall GI symptoms, especially abdominal pain and bloating. In children, only one study reported positive results of a low FODMAPs diet. No effect was found for the lactose free diet whilst fructose-restricted diet was effective in 3/4 studies. The duration of the intervention was very different among the studies, ranging from 2 days to 16 months, and from 3 and 9 weeks for the RCTs. The majority of the trials presented differences in symptoms scoring scales, diet, food diaries, and food frequencies questionnaire. Conclusions The FODMAPs-restricted diet may be an effective dietary intervention for reducing IBS symptoms in adults. In children, there are promising data, although only one randomized double-blind study exists and further data are needed to better clarify the role of FODMAPs and fructose-restricted diet in IBS. The current evidence does not support the use of a lactose-restricted diet in children with FGIDs.

Several tests are available in clinical practice to detect gastroesophageal reflux disease (GERD), including barium contrast radiography and gastroesophageal scintigraphy. Different studies exist about the specificity, sensitivity, and positive/negative predictive values of barium contrast radiography and scintigraphy, considering pH monitoring as the gold standard for the diagnosis of GERD. Barium contrast radiography is useful for the diagnosis of anatomic abnormalities which may be the cause of symptoms similar to GERD. Scintigraphy with 99technetium is a technique proposed as helpful in detecting reflux, gastric emptying, and microaspiration. However, the sensitivity and specificity of both techniques are much lower than those of pH monitoring. In conclusion, according to the last guidelines on GERD, these techniques are not recommended in the routine diagnosis of GER/GERD, but they can exclude other disorders which can simulate GERD.

ACKGROUND AND AIM: Two different subtypes of functional dyspepsia (FD) are recognized in adults: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). The aim of the study was to assess the presence of FD subtypes in childhood at diagnosis and to observe changes at follow-up. METHODS: A total of 100 patients with a diagnosis of FD based on pediatric Rome III criteria were consecutively enrolled. FD subtypes were successively classified through adult Rome III classification. Children were revaluated after 6 months of follow-up (T1). RESULTS: At T0, 17 (17%) of 100 patients were classified as EPS, whereas 47 (47%) of 100 patients fulfilled criteria for PDS. In 36 (36%) of 100 children an overlap between the 2 subtypes was identified. Nausea was significantly higher in PDS and overlap groups when compared with EPS (χ = 21.7, P = 0.0001; χ = 20.7, P = 0.0001). Headache was significantly increased in PDS and overlap groups compared with patients with EPS (χ = 9.8, P = 0.001; χ = 13.1, P = 0.0001, respectively). At T1 among children belonging to PDS group at enrolment, 9 of 47 (19.1%) changed to EPS group, and 9 of 47 (19.1%) changed to the overlap group. Five (29.4%) of 17 patients and 2 (11.8%) of 17 children diagnosed as having EPS at T0 switched to PDS and overlap group, respectively. Of the 36 patients with overlap at enrollment, 11 (30.6%) satisfied criteria for PDS, and 7 (19.4%) switched to EPS group. CONCLUSIONS: Two distinct FD subtypes are identifiable in pediatric population. A high percentage of overlap and a variation of subtype over time were found, suggesting a common pathophysiologic mechanism.

Aliment Pharmacol Ther 2011; 34: 783–789 Summary Background An association between coeliac disease (CD) and functional gastrointestinal disorders (FGIDs) has at present only been demonstrated in adults. Aims To assess the prevalence of FGIDs at 1 year and the role of psychological aspects on the development of FGIDs in CD children. Methods One-hundred consecutive CD children (36M and 64F) were followed up for 1 year. Fifty-six children (25M and 31F) represented the control group. All children and/or their parents completed validated questionnaires for GI symptoms, depression, and anxiety. GI symptoms at diagnosis and after 1 year of gluten-free diet (GFD) were compared. Results Twenty-three/82 (28%) CD patients followed up prospectively, on GFD from at least 1 year, fulfilled the Rome III criteria for FGIDs compared with 5/56 (8.9%) controls (P = 0.008; χ2 = 6.8; OR: 3.97; 95% CI: 1.40–11.21). Children complaining with GI symptoms alone [21/52 (40.3%)] more likely fulfilled Rome III criteria for FGIDs after 1 year of GFD than children with extra-intestinal symptoms (P = 0.045). CD children with FGDIs presented significantly higher anxiety and depression compared to CD children without FGIDs and controls (P = 0.02). Conclusions This study demonstrates that children with CD on a GFD for a year have a much higher prevalence of functional GI symptoms than do controls. Whether the risk is due to the residua of a chronic inflammatory process, and/or due to psychological factors remains to be further tested.

Aliment Pharmacol Ther 31, 754–759 Summary Background Proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) may play an important role on the onset of Clostridium difficile-associated disease (CDAD) in adults. The impact of Clostridium difficile on children treated with gastric acid-suppressing agents remains unknown. Aim To investigate the relationship between CDAD and exposure to acid suppressive therapy in hospitalized paediatric patients. Methods We reviewed the medical records of children, with a diagnosis of protracted diarrhoea and abdominal pain, whose stool was analysed for C. difficile toxins. We identified 68 patients with CDAD. For each patient, we randomly selected one control subjects with stool analysis negative for C. difficile. Comorbid illnesses, previous hospitalizations, antibiotics, corticosteroids, immunosuppressants and gastric acid suppressing exposures were recorded. Results The use of PPI was significantly higher in C. difficile positive group compared with C. difficile negative group [odds ratio (OR): = 4.5; 95% confidence interval (CI) = 1.4–14.4]. We also found a trend for the use of H2RAs in patients infected by C. difficile compared with C. difficile negative comparison group (OR: = 3.8; 95% CI = 0.7–18.9). Conclusions Children exposed to PPIs therapy seem to be at higher risk for the development of Clostridium difficile-associated disease.

Abdominal pain-related functional gastrointestinal disorders (AP-FGIDs) following bacterial acute gastroenteritis (AGE) have been demonstrated in adults and children. An adult study demonstrated AP-FGIDs resulting from an outbreak of viral AGE. Viral AGEs are common in children. Thus, the demonstration of AP-FGIDs occurring after a viral infection in children could constitute a significant finding. The aim of the study was to investigate the development of FGIDs following an episode of acute rotavirus gastroenteritis in children. This is the first pediatric multicenter study designed to assess postviral AP-FGIDs.: It is a cohort study. Inclusion criteria of the study are children ages 4 to 18 years with history of AGE secondary to rotavirus. Sample size is 44 exposed and 44 controls (unidirectional alpha of 0.05, power of 0.80). Children consulting at 2 hospitals (Chicago, IL, and Naples, Italy) for AGE (2002-2004) who tested positive for rotavirus were randomly contacted by telephone2 years after the episode. Each exposed child who visited the emergency department or outpatient site for acute trauma or well-child visit within 4 weeks of the index case was matched with a control of the same age and sex. Gastrointestinal symptoms and disability were evaluated with a validated pediatric questionnaire.: Eighty-eight patients (46 boys, mean age 5.3 years) were recruited. Contacted patients presented with AGE in 2002 (9), 2003 (11), and 2004 (24). Seven (16%) exposed patients and 3 (7%) controls reported AP-FGIDs (P = 0.31).: Our study suggests that rotavirus infection does not seem to place children at increased risk for AP-FGIDs at long-term follow-up. Larger, prospective studies should be conducted to evaluate whether rotavirus gastroenteritis leads to AP-FGIDs in children.

Mucopolysaccharidosis (MPS) IIIB (Sanfilippo syndrome, OMIM 252920) is a lysosomal storage disorder caused by the deficiency of α-N-acetylglucosaminidase (NAGLU), a lysosomal hydrolase involved in the degradation of heparan sulphate (HS) (1). MPS IIIB is characterized by multisystem involvement and a complex phenotype. The most debilitating manifestations of the disease are those related to central nervous system disease, with severe and progressive mental retardation, hyperactivity, and behavioral problems. Skeletal and visceral manifestations are less prominent, as compared with other MPS. Gastrointestinal manifestations, including diarrhea and constipation, have occasionally been described in patients with MPS IIIB, but they have been poorly characterized and their pathophysiology is not known. Although gastrointestinal symptoms are often overshadowed by the severe neurological phenotype, they may affect the quality of life of patients and of their families. We describe a case of MPS IIIB, referred to our hospital because of chronic diarrhea, in which abnormalities of intestinal endoscopy, histology, and scintigraphy with Tc-99m-labeled human serum albumin were found, partially overlapping with the features of intestinal lymphangiectasia. In this patient, a low-fat diet and supplementation of medium-chain triglycerides were started, leading to persisting improvement of diarrhea. These results add information on the pathophysiology of intestinal manifestations in MPS IIIB patients and possibly in other MPS patients with a history of chronic diarrhea.

This multicenter prospective study aimed to establish possible risk factors for functional constipation (FC) in the first year of life.At the infant's age of 3, 6, and 12 months, parents of all included infants completed 2 questionnaires: one about the presence of FC and the other screened the possible risk factors for FC. Parents of 465 infants completed the questionnaires at 3 and 6 months and of 402 infants at 12 months of life.According to the Rome III criteria, FC was found in 11.6% of the infants at 3 months, in 13.7% at 6 months, and in 10.7% at 12 months after birth. Family history of atopy was present in 38.8% and 45.3% of infants with constipation at 3 and 6 months (P = 0.04 and P = 0.02, respectively), but no significant association was found at 12 months (P = 0.80). Breast-feeding was significantly related to a normal evacuation pattern at 3 months (P = 0.05), but not at 6 and 12 months (P = 0.12 and P = 0.9, respectively). Acetaminophen and female sex appeared to be risk factors for FC at 12 months. After the adjustment for all analyzed variables, FC in infants was significantly associated with the use of acetaminophen (odds ratio 6.98, 95% confidence interval 0.82-13.50).Our results confirmed that breast-feeding is a protective factor for FC in the first 3 months of life and that the female sex is at risk to have FC. We found that the use of acetaminophen was associated with a higher incidence of FC in the first year of life.

Objectives To prospectively investigate the occurrence of postinfectious functional gastrointestinal disorders (FGIDs), diagnosed according to the Rome III criteria, in children with acute diarrhea of different infectious etiology. Study design This was a prospective cohort multicenter study. Children 4-17 years of age presenting with acute diarrhea who tested positive for an enteric infection were recruited within 1 month from the episode and matched with control subjects of similar age and sex. Symptoms were evaluated with a validated questionnaire for FGIDs at the time of enrollment in the study and after 3 and 6 months. Results A total of 64 patients (36 boys; median age 5.3 years; age range 4.1-14.1 years) were recruited, 32 subjects in each arm. Infections included rotavirus (56.8%), salmonella (30%), adenovirus (6.6%), norovirus (3.3%), and Giardia lamblia (3.3%). FGIDs were significantly more common in exposed patients compared with controls within 1 month from acute diarrhea (40.6% vs 12.5% [ P = .02, relative risk (RR) = 1.9]), 3 months (53% vs 15.6% [ P = .003, RR = 2.2]), and 6 months (46.8% vs 15.6% [ P = .01, RR = 1.9]) later. No correlation was found between different etiologies, age, or sex, and any type of FGIDs. Among exposed children, abdominal pain–related FGIDs were significantly more frequent compared with controls after 6 months from infection ( P = .04, RR = 1.7). Conclusion This prospective cohort multicenter study supports postinfectious FGIDs as a true entity in children. There seems to be a significant increase in abdominal pain–related FGIDs after acute diarrhea in children within 1 month and 3 and 6 months later.

Objectives To assess the prevalence of irritable bowel syndrome (IBS) subtypes in childhood at diagnosis and their changes over 1 year. Study design This is an observational, prospective, multicenter study. Consecutive pediatric patients with IBS, according to Rome III criteria, were enrolled over a 1-year period. Parents recorded weekly stool frequency and consistency and gastrointestinal and extraintestinal symptoms in a diary. Stool consistency was scored according to the Bristol Stool Form Scale. Children were evaluated after 2, 3, 6, and 12 months. Results We enrolled 100 children with IBS (median age 9.9 years, range 4.2-16.7 years, 52 girls and 48 boys). At time of enrollment, constipation-IBS was the prevalent subtype (45%), with a prevalence of girls at 62% (P < .005); diarrhea-IBS was reported in 26% of children, with a prevalence of boys at 69% (P < .005); and alternating-IBS was described in 29% of children, without a difference between sexes. During the follow-up, 10% of patients changed their IBS subtypes at 2 months, 9% at 3 months, 7% at 6 months, and 6.3% at 12 months. Twenty-four percent of patients changed IBS subtype between the time of enrollment and 12 months. Conclusions Constipation-IBSis the prevalent subtype in children, with a higher frequency in girls. Inboys, diarrhea-IBS is the most common subtype. It is important to acquire knowledge about IBS subtypes to design clinical trials that may eventually shed new light on suptype-specific approaches to this condition.

Infants affected by neuroblastoma with symptomatic epidural compression require early diagnosis and appropriate treatment to avoid severe late complications. However, no established guidelines are available regarding the optimal treatment of these patients. We describe 5 such infants. The interval between the onset of symptoms and tumor diagnosis was 3 to 8 days in 4/5 cases. None developed paraplegia before or after treatment. Treatment for epidural compression included first-line laminoplasty followed by chemotherapy in 3 patients, and chemotherapy first in the remaining 2. To date, all are alive and none have developed severe complications after a follow-up of 9 to 39 months (median, 20).

R. Turcoa, M. Russoa, R. Mastroianni a , L. Pensabeneb , L. Grecoa, A. Staianoa, A. Campanozzi c , O. Borrelli d , C. Romanoe, G. Guariso f aDepartment of Pediatrics, University of Naples “Federico II”; bDepartment of Pediatrics, University “Magna Graecia” of Catanzaro; cDepartment of Pediatrics, University of Foggia; dDepartment of Pediatrics, University of Rome “La Sapienza”; eDepartment of Pediatrics, University of Messina; fDepartment of Pediatrics, University of Padua

Mechanism underlying the occurrence of Gastroesophageal reflux disease (GERD) in neurologically impaired children (NIC) is poorly understood. We sought to characterize, by Esophageal High Resolution Manometry (EHRM), alterations of esophageal motility associated with GERD in NIC and to compare with a group with a suspicion of GERD and normal psychomotor development (NDP).

s / Digestive and Liver Disease 46 (2014) e71–e84 e81 genotyped by DMET technology, with colon cancer and GI toxicity induced by irinotecan. Conclusions: In conclusion, according to our preliminary findings, the heterozygous genotype G/A in the (rs55802895) NR1I3 gene seems to be associated with the altered gastrointestinal function in FD. http://dx.doi.org/10.1016/j.dld.2014.07.043 EFFECT OF MAGNESIUM ALGINATE PLUS SIMETHICONE ON GASTROESOPHAGEAL REFLUX IN INFANTS: A RANDOMIZED, OPEN TRIAL Dario Ummarino ∗, Erasmo Miele, Massimo Martinelli, Elena Scarpato, Felice Crocetto, Elisa Sciorio, Annamaria Staiano Dipartimento di Scienze Mediche Traslazionale, Sezione Pediatria, Universita degli Studi di Napoli Federico II, Napoli, Italy Objectives: Gastroesophageal reflux (GER) is a frequent condition in infants that can cause distressing symptoms. The aim of our study is to evaluate the efficacy of Mg-alginate plus simethicone (Gastrotuss Baby®), compared to rice-starch-thickened formula or to reassurance alone, in the treatment of GER in infants. Methods: This randomized, controlled trial was conducted in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (I-GERQ-R). The patients were randomized in3groups according to treatment [GroupA:Mgalginate plus simethicone (Gastrotuss Baby®); Group B: Thickened formula; Group C: reassurance with lifestyle changes]. The evaluation of the symptom scores was performed after one month (T1) and two months (T2). Results: Sixty-four (85.3%) out of 75 enrolled infants (median age: 5 months; range: 1–10), concluded the study. After one month of treatment (T1), infants treated with Mg-alginate plus simethicone (Gastrotuss Baby®) showed a statistically significant improvement of symptoms compared with the thickened formula and reassurance (p 24 months (p 0.0001) and was similar in the two decades. Conclusions: Our study showed that IFALD occurs early in the natural history of SBS. This suggests that it may depend on the underlying disease and on its early complications (repeated surgery, sepsis) rather than the factors related to the PN duration. This is also supported by the evidence of the unchanged prevalence of IFALD over the years in spite of advances in the PNmanagement. http://dx.doi.org/10.1016/j.dld.2014.07.045 WAIST TO HEIGHT RATIO: A SIMPLE TOOL TO RECOGNISE CHILDREN AT INCREASED RISK FOR METABOLIC SYNDROME Angelo Campanozzi1,∗, Irene Rutigliano1, Donatella De Giovanni1, Michela Foglia1, Mariangela Guglielmi1, Gianpaolo De Filippo2, Luciana Romaniello1, Valentina De Maio1, Michele Conoscitore1, Massimo Pettoello-Mantovani1 1 Clinica Pediatrica, Universita’ di Foggia, Foggia, Italy 2 Pediatria, Ospedale Bicetre, Parigi, France Objective: Metabolic Syndrome (MS) is the most important comorbidity obesity-related, also in children. Visceral adiposity is part of MS cluster, so that measurement of Waist Circumference (WC) is an essential step for screening MS in adulthood and childhood. Up today, valid cut-off percentiles for WC are not available for the whole pediatric population, arising difficulties to diagnose the MS. Aim of the study: To individuate a simple clinical diagnostic tool for screening obese children at risk for MS. Methods:Weenrolled in the study803 subjects (395girls,mean age 9.43±2.5 yrs) whose mean BMI z-score was 2.2±0.53. The

Background: Bloating and objective abdominal distention are considered gas-related symptoms and while they are related, they may represent expressions of different underlying pathophysiological process and have different response to treatment.1-2 Therefore, the efficacy of 100 mg pinaverium bromide + 300 mg simethicone (PB+S) over these symptoms, was studied in a 12-week randomized placebo-controlled trial. Methods: We studied 285 IBS-Rome III patients. They all filled-out a 12-week questionnaire that included 10-cm visual analog scales (VAS) for evaluating the intensity abdominal pain and bloating, and registered their girth circumference (objective distension) early in the morning and before bedtime during weeks 1, 6 and 12 of treatment. Data was analyzed with ANOVA for repeated measurements, using as covariate the linear combination of the girth measurements during all the weeks (explained 78% to 80% of the total variance). Finally, the abdominal volume was calculated with a mathematical model: (circumference cm)3/[6π2]. Results: Patients were 37±9 years old, F: 83%, BMI: 27±5, and were classified as IBS-C: 44%, IBS-D: 23%, IBS: 31%, and IBS-U: 2%. They reported a significant decrease in abdominal pain and bloating favoring PB+S vs. placebo (Size effect: 23% and 21% respectively, p