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Diarrhea clinical trials

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NCT ID: NCT01691248 Completed - Clinical trials for Clostridium Difficile-Associated Diarrhea (CDAD)

Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)

DEFLECT-1
Start date: October 10, 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.

NCT ID: NCT01670149 Completed - Clinical trials for Clostridium Difficile Infection

Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

RAPID
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.

NCT ID: NCT01667627 Completed - IBS Clinical Trials

Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea

IBS-D
Start date: January 2014
Phase: Phase 4
Study type: Interventional

We present the study design of a clinical trial designed to assess the clinical effects of the multispecies probiotic combination "BIO-25" in IBS-D patients. To this aim the primary endpoints of the study will be improvement in abdominal pain and stool consistency. The study will also be designed and powered to investigate the effect of the probiotic BIO-25 on the putative inflammation-associated parameters related to microinflammation in IBS, using postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic status.

NCT ID: NCT01657032 Completed - Diarrhea Clinical Trials

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

NCT ID: NCT01637389 Completed - Diarrhea Clinical Trials

Evaluation of Safe-Water Programs in Baja California Sur, Mexico

Start date: July 2009
Phase: N/A
Study type: Interventional

Fundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico (BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The premise of their safe drinking-water programs has been the installation of household drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed at the University of California, Berkeley. While the systems have been tested for safety and effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously evaluating the impact of their safe drinking-water program at the population level. FCA is looking to expand their safe-water program during 2009 and 2010 to newly identified communities that lack safe-drinking water. In order to evaluate the community level effectiveness of their program FCA has agreed to randomize the timing of this expansion which will allow the lead investigators and key personal in this protocol to conduct a meaningful, scientific evaluation of the impact of their program through a randomized stepped wedge design. The research described in this protocol has four (4) primary objectives: 1. To evaluate the impact the implementation of the safe drinking-water programs has on rates of gastrointestinal events in rural BCS communities; 2. To evaluate the impact of the safe drinking-water programs on concentrations of fecal contamination in household drinking-water in rural BCS communities; 3. To evaluate other-health and non-water impacts on communities where the safe-water programs are implemented, including school and work absenteeism, and health care costs; 4. To identify household, program and system design characteristics that affect user compliance with the disinfection strategies. The investigators hypothesize that households that receive an UV based drinking-water disinfection system through the safe-water program will have reduced prevalence of gastrointestinal illness, and reductions in fecal contamination of household drinking-water, measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the investigators hypothesize that these communities will also have reduced health care costs, and school and work absenteeism due to the implementation of the safe drinking-water programs. The investigators further hypothesize that household level characteristics and specific program characteristics will differentially impact user compliance, measured as the sustained use of the systems over the course of the study. In order to evaluate the last hypothesis (Objective 4) two program variations will be rolled out to inform future programmatic decisions. A priori the investigators do not anticipate that these program variations will impact population measures for Objectives 1 and 2, but the investigators will explore these assumptions during analysis.

NCT ID: NCT01598311 Completed - Clinical trials for Clostridium Difficile Infection

A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

NCT ID: NCT01597505 Completed - Clinical trials for Clostridium Difficile Infection

Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

NCT ID: NCT01591863 Completed - Clinical trials for Clostridium Difficile-associated Diarrhea

Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Start date: June 15, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT01585025 Completed - Chronic Diarrhoea Clinical Trials

Obeticholic Acid in Bile Acid Diarrhoea

OBADIAH1
Start date: April 2012
Phase: Phase 2
Study type: Interventional

The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective treatment.

NCT ID: NCT01577043 Completed - Clinical trials for Acute Gastroenteritis

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.