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Diarrhea clinical trials

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NCT ID: NCT02328547 Completed - Clinical trials for Irritable Bowel Syndrome

Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome

Start date: May 2015
Phase: Phase 2
Study type: Interventional

The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.

NCT ID: NCT02324075 Completed - Diarrhea Clinical Trials

Using Behaviour Change Messaging to Improve Communal Toilets in Dhaka, Bangladesh

WSUP
Start date: December 2014
Phase: N/A
Study type: Interventional

Background (brief): 1. Burden: In low income neighborhoods in Dhaka many households share toilets which are often unsanitary and their discharge contaminates the community. 2. Knowledge gap: Behavior change messages have the potential to make people concerned about maintaining shared toilets quality, cleanliness and safety of the facility. There are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's not clear that the situation can be improved with behavior change or even which specific messages to target. 3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization working to improve shared sanitation facilities in Dhaka. They are interested in developing and evaluating a behavior change program to improve shared sanitation in Dhaka and to generate lessons that would be relevant for other low income urban settings globally. Hypothesis: A behavior change communication intervention can improve the quality and cleanliness of sanitation services available to low-income residents of Dhaka. Objectives: 1. To deliver behavior change messages (which target key behaviors influencing the quality and cleanliness of shared sanitation facilities) to randomly selected low-income communities in Dhaka. 2. To evaluate the effectiveness of a behavior change communication intervention designed to change targeted behaviors related to the quality and cleanliness of shared sanitation facilities. Methods: Local non-governmental organizations will deliver the intervention (behavior change communication package) in randomly selected communities. For this study the investigators will assess the impact of this intervention on the targeted behaviors using follow-up surveys and spot checks.

NCT ID: NCT02320318 Withdrawn - Clinical trials for Irritable Bowel Syndrome With Diarrhea

12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

IRIS-05
Start date: October 2015
Phase: Phase 3
Study type: Interventional

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

NCT ID: NCT02318992 Completed - Clinical trials for Recurrent C. Difficile Associated Diarrhea

Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.

NCT ID: NCT02294786 Terminated - Cancer Clinical Trials

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer

Start date: December 17, 2014
Phase: Phase 2
Study type: Interventional

Diarrhoea is the most commonly reported adverse event (AE) associated with Lapatinib treatment, and is also commonly associated with Capecitabine treatment. Although these events are generally mild to moderate in severity, diarrhoea adversely affects the tolerability of cancer treatment, and in severe cases diarrhoea has the potential to affect the efficacy of treatment due to poor compliance, or treatment interruption or withdrawal. The efficacy of Octreotide in the management of cancer treatment-associated diarrhoea has not been extensively evaluated in large, well-controlled studies. This is a randomised, multi-centre, open-label Phase II study in subjects with Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer which has progressed following prior therapy, which must have included anthracyclines and taxanes and therapy with Trastuzumab in the metastatic setting. This study is not placebo controlled, and there is no active comparator. The study evaluates whether the prophylactic use of Octreotide Long Acting Release (LAR) offers a clinically meaningful benefit by reducing the frequency and severity of diarrhoea associated with treatment with Lapatinib and Capecitabine. Study completion for a subject is defined as the completion of 24 weeks of treatment with Lapatinib and Capecitabine, or progression of cancer or the death of the subject during treatment, whichever occurs first. Approximately 140 subjects were planned to be randomized out of which 70 were planned to receive octreotide and 70 were planned to receive no Octreotide.

NCT ID: NCT02291575 Completed - Asthma Clinical Trials

Improving the Quality of Private Sector Health Care in West Bengal

Start date: October 2012
Phase: N/A
Study type: Interventional

The rural healthcare market in much of the developing world is composed largely of informal private providers. These private providers often have little to no certifiable medical training. Recent studies in India using medical vignettes (or hypothetical medical situations) to measure clinical competence and direct observations of doctor-patient interactions to measure clinical practice highlight the poor quality of care that most patients receive—a problem that is clearly relevant beyond India and affects most low-income countries worldwide. For instance: 1. In rural India, standardized patients presenting with chest pain and (on further questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in less than 25 percent of cases. 2. Across 8 low and middle-income countries, health care providers completed the four necessary vital statistics for new patients in less than 4 percent of interactions: health care providers in the public sectors of many developing countries routinely spend less than 1 minute per patient. To address these deplorably low standards in both medical knowledge and practice, the Liver Foundation in Kolkata has been working with private rural health care providers through capacity building activities to improve quality in the private sector. The program consists of multiple-week training to private rural health care providers on the basis of a well-developed curriculum in the district of Birbhum, West Bengal. This study aims to assess the impact of this training program using a randomized evaluation, in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's training program, or the control, i.e. no such training. As an independent outside evaluation team, we will run a baseline survey for all providers (through a third party data collection agency), monitor the application of and compliance in the Liver Foundation's training intervention, and conduct a final endline study. By comparing the treatment and control groups on a variety of measures developed to capture competence in provider knowledge and practice, we can rigorously assess whether such a training program for informal rural health care providers is an effective means of improving provider medical knowledge and practice in the short run. It is worth noting that this study will not be able to capture long run effects , such as price or location changes, on health care for the rural poor.

NCT ID: NCT02286895 Completed - Diarrhea Rotavirus Clinical Trials

Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

Start date: October 2014
Phase: Phase 4
Study type: Interventional

This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.

NCT ID: NCT02280044 Completed - Diarrhea Clinical Trials

Efficacy of Rifaximin in Preventing Campylobacteriosis

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.

NCT ID: NCT02246010 Terminated - Clinical trials for Acute Gastroenteritis

Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.

NCT ID: NCT02245139 Completed - Diarrhea Clinical Trials

Surveillance Study of Acute Gastroenteritis in Hospitalized Children

SAGE
Start date: July 1, 2014
Phase: N/A
Study type: Observational [Patient Registry]

Acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.