To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation...
RegurgitationGastric1 moreA randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious...
Acquired Immunodeficiency SyndromeHealthy Volunteers3 moreThis study is intended to evaluate: Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice daily (BID) following one month of treatment. The safety and tolerability of crofelemer, (Mytesi) delayed release 125 mg tablets BID in healthy (HIV-negative) volunteers and HIV+ patients following one month of treatment.
Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea
Bile Acid MalabsorptionChronic DiarrheaBile acid diarrhoea is a chronic disease that impairs quality of life. One in 100 has the condition and many suffer from the disease without knowing. The current test is called SeHCAT and is expensive and time-consuming and is unavailable in many places, including the US. The disease is often misdiagnosed as irritable bowel syndrome and estimated one third of patients with irritable bowel syndrome of the mixed type and the diarrhoea predominant type suffer from bile acid diarrhoea without knowing. A blood test called 7α-hydroxy-4-cholestene-3-one (C4) could make it much easier to diagnose bile acid diarrhoea. To establish the new test, the results of both C4 and SeHCAT are compared with the treatment effect of the drug called colesevelam. We invite patients who are referred for the SeHCAT test to participate in the trial. The SeHCAT test takes two days that are one week apart. The study patients register stool habits with a diary in the week between the SeHCAT visits. Based on the diary results, we screen for eligibility; e.g. a certain degree/severity of diarrhoea is required for participation. We treat eligible study patients (i.e those with diarrhoea) with either colesevelam or placebo (medicine without effect) that is randomly assigned. 170 study patients need to complete the treatment. We aim to validate (ie. compare) both the C4-test and the SeHCAT test with the colesevelam treatment response as the reference.
Incidence and Severity of Diarrhea in Patients With Stage II-IIIC HER2 Positive Breast Cancer Treated...
HER2-positive Breast CancerBreast Adenocarcinoma7 moreThis phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.
Antibiotics for Children With Severe Diarrhoea
DiarrheaAlthough the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth. The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.
Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea
Acute DiarrheaA pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who received only SOR. Both groups received treatment for seven days, respectively. Patients of Group 1 stopped for their own choice, SOR after the first 24 h and continued only with Actitan F.
Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease
ColchicineDiabetes Mellitus5 moreThis study is designed to investigate dose-dependent effects of low dose colchicine on inflammatory responses, endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation. This study also tested the relationship between doses and safety issue such as incidence of diarrhea. Eligible patients will be randomly allocated to three treatment group: colchicine at 0.5mg per day, 0.25mg per day or placebo for 12 weeks in a double blind , parallel group design. High sensitive-CRP at 4 weeks as primary end point and flow mediated vasodilatation at 12 weeks as the secondary end point will be measured.
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
DysenteryShigella2 moreThe purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City.
FODMAP Reintroduction in Irritable Bowel Syndrome
Irritable Bowel Syndrome With DiarrheaIrritable Bowel Syndrome With Mixed Bowel HabitsThe purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS; however it is unclear how patients can successfully reintroduce and liberalize fructose into their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content and gas production in the bowel and also possibly by altering gut bacteria. Although use of the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of patients, the reintroduction diet is difficult for patients to complete and maintain for long periods of time because current methods for reintroduction of FODMAPs are imprecise leading to frequent recurrent symptoms. As a result, patients often continue the low FODMAP elimination diet for additional months because they have difficulties knowing how to add back FODMAPs into their diet. There are no studies to date to help guide patients with FODMAP reintroduction.
Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated...
DiarrheaClostridium DifficileThe objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea. The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU. The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.