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Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for Helicobacter pylori (H. pylori). This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-na&iuml, ve adults with H. pylori infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The H. pylori eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received &ge, 1 dose of study drug and had test-of-eradication performed 28&ndash, 35 days post-completion of therapy, was compared (one-sample Z-test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT H. pylori eradication rate (95% CI) with RHB-105 of 89.4% (82.0&ndash, 96.8%) was greater than both the literature-derived comparator rate (P &lt, 0.001) and the standard-of-care rate of 63.0% (44.8&ndash, 81.1%) (P = 0.006). Adverse events with an incidence &ge, 5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia&reg, ) proved to be a safe and effective empiric therapy for H. pylori eradication.

Oral prescription medical foods have long been used in hospital settings but are also appropriate therapies for gastrointestinal disorders in outpatient medical practice. Oral serum-derived bovine immunoglobulin/protein isolate (SBI) has been shown in clinical studies to reduce loose stools and improve stool consistency as well as other symptoms (i.e., abdominal pain, bloating, and urgency) in patients with irritable bowel syndrome with diarrhea (IBS-D) and human immunodeficiency virus-associated enteropathy. This case series reports the outcomes of 14 IBS patients who received SBI as an addition to standard of care at an individual physician's clinical practice. The patients: 2 IBS with constipation (IBS-C), 7 IBS-D, 2 mixed diarrhea and constipation IBS (IBS-M) and 3 undefined IBS (IBS-U; also described by some physicians as IBS-Bloating), ranged in age from 22-87 years. SBI (5 g or 10 g daily dose) was added to the patient's current standard care and followed for several weeks to determine if symptoms were improved with the addition of SBI. Overall, 12 of the 14 patients indicated some level of improvement through direct questioning of the patients regarding changes from the prior visit. One IBS-Bloating patient had a resolution of symptoms and two patients (1 IBS-Bloating and 1 IBS-C) discontinued therapy because of insufficient relief. The 12 patients who continued on therapy reported an overall improvement in symptoms with better stool consistency, decreased frequency as well as reductions in abdominal pain, bloating, distention, and incontinence. In most cases, therapeutic effects of SBI were seen within the first four weeks of therapy with continued improvements at subsequent visits. SBI has a multifaceted mechanism of action and may help to manage IBS by providing a distinct protein source required to normalize bowel function, gastrointestinal microbiota, and nutritionally enhance tight junction protein expression between intestinal epithelial cells. SBI as a medical food provides a safe option for patients with IBS-D but may have application in other forms of IBS.

Introduction: There is poor oral health awareness in Nigeria because of limited access to correct information on oral health as well as a lack of oral health-care providers. The purpose of this study was to describe the roles of community pharmacists (CPs) in Plateau State, Northern Nigeria, as sources of oral health information in their communities. Methods: A quantitative cross-sectional study on CPs spanning the entire State. Data collection was a survey method using a structured paper-based self-administered questionnaire. Analysis, which included t-tests and binary logistic regression, was carried out using SPSS ver. 23. Results: A one-sample t-test to assess the attitudes of CPs on oral health showed that they had a very good disposition towards engaging in oral health services [advice, referrals, recommendations and basic treatment (e.g. of pain); mean = 4.54, standard deviation = 0.59, t(111) = 27.8, P < 0.001]. Although CPs presently provide some services to patients with oral health problems, 94.7% were willing to do more to advance the cause of oral health care. Training of CPs on oral health (32%), removal of restrictive policies in the health bill (1.8%) and sensitising the public (6.3%) were some suggestions on how to improve these services. Conclusion: The disposition of CPs towards improving oral health could serve as a platform to help propagate oral health care and awareness in their communities. Engaging the CPs might help to reduce oral health disparities by increasing oral health awareness and improving the quality of life via cost-effective delivery of pharmacy-based oral health-care services.

Purpose: To examine clinical practice effectiveness of a medical food containing serum-derived bovine immunoglobulin (SBI) for the management of symptoms in irritable bowel syndrome with diarrhea (IBS-D) patients. Methods: From 165 IBS-D patient medical charts [mean age=59.6 years (range: 19-98), female (n=109), Caucasian (n=144)], recorded daily stools/consistency, abdominal pain, and patient/ physician reported quality of life (QoL) scores were retrospectively collected on those prescribed SBI for a minimum of 8 weeks. A generalized estimating equations model was used to analyze and compare changes for scores of symptoms and QoL. Results: Where data existed in charts, 46% of patients on SBI had a combined mean score reduction in daily stools, improvement in stool consistency (Bristol Stool Scale from >5 to

Summary Background Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities. Aim To demonstrate the long-term safety, tolerability and patient outcomes of lubiprostone in patients with IBS-C. Methods This extension study enrolled 522 IBS-C patients who had completed one of two randomised phase 3 studies. All enrolled patients received open-label lubiprostone orally for 36-weeks (8 mcg, twice daily). The primary objective was the assessment of long-term safety and tolerability, monitored via adverse events (AEs), laboratory parameters and vital signs. Additional outcome endpoints included monthly responder rates and patient evaluations of IBS-C symptom severity and impact on quality of life. Results The evaluable safety population comprised of 520 patients; 476 of which had patient reported outcome data available. The overall safety profile of lubiprostone during this study was similar to that observed in the preceding phase 3 studies. The most common AEs were diarrhoea (11.0%), nausea (11.0%), urinary tract infection (9.0%), sinusitis (9.0%) and abdominal distention (5.8%). Diarrhoea and nausea were the most common treatment-related AEs. No serious AEs were considered treatment-related. Seventeen patients discontinued due to a treatment-related AE, of which diarrhoea and nausea accounted for six (1.2%) and three (0.6%) respectively. For responder rates and patient-evaluated parameters (n = 476), all groups experienced significant improvements from baseline, with initial improvements maintained throughout the study. Conclusion In patients with irritable bowel syndrome with constipation, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9–13 months of treatment.

Summary Background Effective treatments for irritable bowel syndrome with constipation (IBS-C) are lacking. Aim To assess the efficacy and safety of lubiprostone in IBS-C. Methods A combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS-C in two phase-3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven-point Likert scale ranging from significantly relieved (+3), to significantly worse (−3), patients responded on their electronic diary to the question: ‘How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?’. The primary efficacy endpoint was the percentage of overall responders. Results Using an intent-to-treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone-treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P = 0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo. Conclusions The percentage of overall responders based on patient-rated assessments of IBS-C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.

Background: Serum-derived bovine immunoglobulin/protein isolate (SBI), a specially formulated oral protein source of >50% IgG and ~60% total immunoglobulins, has a multifaceted mechanism of action binding microbial components, maintaining gastrointestinal immune balance, managing gut barrier function and improving nutrient utilization. IBD animal models and a human refractory case study demonstrated that SBI can attenuate both inflammatory biomarkers and histological parameters in the bowel. Additionally, SBI is intended for the clinical dietary management of intestinal disorders due to limited/impaired capacity to ingest, digest, absorb or metabolize certain nutrients/foodstuffs or clinical dietary management of chronic loose and frequent stools. Given the known efficacy of SBI in gastrointestinal disorders and effects demonstrated in IBD animal models, SBI may help in the nutritional management of Inflammatory Bowel Disease (IBD) patients. Methods: In a clinical practice setting, we retrospectively evaluated seven ulcerative colitis (UC) and Crohn’s disease (CD) patients who incorporated SBI into their therapeutic regimens. All patients previously failed to adequately respond to conventional drug therapies. Their SBI response was assessed to determine its effect on further management in IBD patients. Results: The addition of SBI for nutritional management resulted in improved IBD symptoms including chronic loose and frequent stools. The UC patients reported resolution of symptoms such as rectal bleeding, urgency, and/or nocturnal incontinence. The CD patients reported weight improvements, other therapy reductions, and/or decrease ileostomy output and creatinine levels. Conclusion: Although this was a retrospective assessment of a small case series, the evidence suggests that SBI provided further management of IBD patients who were not fully controlled on traditional therapies by providing for distinctive nutritional requirements in these patients. Further study is warranted to evaluate this option as part of IBD therapy.

Aims: The purpose of this study was to assess the knowledge of oral health of community pharmacists (CPs) in Plateau State, Northern Nigeria, serving as a template upon which they can be engaged as a medium to improve oral health care among the people. Materials and Methods: A quantitative cross-sectional study on CPs spanning the entire State. Results: CPs (113) were recruited as participants. A one-sample t-test showed good knowledge of oral health by the CPs: mean = 17.2, standard deviation (SD) = 2.44, t (112) = 5.14, P

Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder consisting of abdominal discomfort/pain, • bloating, and altered bowel habit not explained by structural or biochemical abnormalities. The prevalence of IBS in Western countries is 10-15%. In the USA more than 30 million people suffer from IBS. • – Up to 30% suffer with constipation-predominant IBS (IBS-C). – IBS affects more females than males, at a ratio of 2:1. Individuals with IBS-C experience substantial decrements in the quality of life and their ability to perform activities • of daily living. Lubiprostone, a selective activator of type-2 chloride channels (ClC-2), is approved for the treatment of chronic • idiopathic constipation in adults and for the treatment of IBS-C in adult women. Lubiprostone enhances fluid secretion into the intestinal lumen without altering serum electrolyte levels. • Patients with IBS may exhibit abnormal gut permeability and an associated intestinal inflammatory response. • Lubiprostone stimulates recovery of mucosal barrier function in animal models suggesting a possible mechanism for the clinical improvement observed in patients on this drug.* In 2 previous double-blinded placebo-controlled phase 3 trials in patients with IBS-C, lubiprostone (16 mcg) was • found to be efficacious and well-tolerated for 12 weeks.

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder with an estimated prevalence of 10–15% in Western countries. • Diagnosis of IBS is based upon the presence of abdominal discomfort/pain with changes in bowel habits. In clinical practice and research, IBS patients are • subgrouped on the basis of differences in bowel habits. Approximately 1/3 of IBS patients suffer with IBS and constipation (IBS-C). Current therapies for IBS-C tend to target relieving individual symptoms of constipation, abdominal pain or bloating rather than the totality of IBS symptoms. • Lubiprostone, a selective activator of type-2 chloride channels (CIC-2), is approved for the treatment of chronic idiopathic constipation in adults and for the • treatment of IBS-C in adult women. Lubiprostone enhances fluid secretion into the intestinal lumen without altering serum electrolyte levels. • Patients with IBS may exhibit abnormal gut permeability and an associated intestinal inflammatory response. Lubiprostone stimulates recovery of mucosal • barrier function in animal models suggesting a possible mechanism for the clinical improvement observed in patients on this drug.* Given the intermittent nature of IBS-C symptoms, short-term interventions for symptomatic relief of IBS-C may be appropriate in some patients. Such • interventions need to be efficacious and not associated with rebound effects following discontinuation of treatment.