Clinical Trials Logo

Diarrhea clinical trials

View clinical trials related to Diarrhea.

Filter by:

NCT ID: NCT01855711 Completed - Irritable Colon Clinical Trials

Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)

Start date: September 18, 2003
Phase: Phase 2
Study type: Interventional

This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and (ii) to obtain reference data for endpoints and dosage and administration of a next phase study.

NCT ID: NCT01849107 Completed - Diarrhea Clinical Trials

Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

Start date: April 2013
Phase: N/A
Study type: Interventional

Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.

NCT ID: NCT01839721 Completed - Cancer Clinical Trials

Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

Start date: December 2006
Phase: Phase 3
Study type: Interventional

In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.

NCT ID: NCT01837940 Completed - Constipation Clinical Trials

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.

NCT ID: NCT01836731 Completed - Malaria Clinical Trials

Impact Evaluation of Community-Based Health Programs in Rwanda

CBEHPP
Start date: April 2013
Phase: N/A
Study type: Interventional

Community Health Clubs to improve local sanitation, hygiene and health conditions have been implemented in several countries in Africa and Asia with some success. The Ministry of Health in Rwanda has committed to rolling out a program designed along similar lines, the Community Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages across Rwanda. The main objective of the program is to achieve 'zero open defecation' in all villages of Rwanda, at least 80% hygienic latrine coverage and improvements in a range of health behaviors such as the use of mosquito nets, hand-washing with soap and the use of household water treatment. To evaluate the impact of the program on health, other socio-economic outcomes and community functioning, a single district has been chosen where 150 communities will be randomized to receive the intervention immediately or 18 months later. The evaluation is led by US based Innovation for Poverty Action (IPA) through researchers based at the National University of Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York University. The research team will work in close collaboration with the implementing team, which consists of the Ministry of Health, Rwanda and Africa AHEAD. The study will span three years, beginning in May 2013, and ending in late 2015.

NCT ID: NCT01832636 Completed - Malnutrition Clinical Trials

Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy

IMAGINE
Start date: October 2013
Phase: Phase 3
Study type: Interventional

Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alterations in intestinal barrier function that lead to malabsorption, growth failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea. Recent studies from Northeast Brazil demonstrate the benefits of a novel alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the recovery of damaged intestinal barrier function in cell culture, animal models, patients with AIDS, and underweight children. Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves short-term gut integrity and weight velocity 4 months after therapy in a group of undernourished children from Northeast Brazil. Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves intestinal barrier function, intestinal inflammation, and nutritional status in children at risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts these benefits?

NCT ID: NCT01823952 Terminated - Diarrhea Clinical Trials

High Amylose Maize Starch for Treatment of Cholera

RESTORS
Start date: April 2013
Phase: N/A
Study type: Observational

A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS, HAMS 6% Acetate HO-ORS and HO-ORS. The primary hypothesis is that at least one of the hypo-osmolar ORS containing high amylose maize starch 6% acetate (HAMSA6-HO-ORS), hypo-osmolar ORS containing high amylose maize starch 2.5% acetate (HAMSA2.5-HO-ORS) and a hypo-osmolar ORS containing high amylose maize starch (HAMS-HO-ORS), will significantly reduce diarrhea duration compared with hypo-osmolar (HO) ORS. Specifically, the investigators expect that HAMSA6 will be the most effective preparation.

NCT ID: NCT01823939 Completed - Diarrhea Clinical Trials

PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera

PISCES
Start date: May 2013
Phase: Phase 1
Study type: Interventional

This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients. This is not a hypothesis-driven research study.

NCT ID: NCT01822028 Completed - Diarrhea Clinical Trials

Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®

Start date: March 2013
Phase: Phase 1
Study type: Interventional

Cross-over, tolerability study with healthy subjects taking Zavesca in combination with Florastor. Forty-two subjects will be randomized to one of two treatment sequences of Zavesca with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected throughout the seventy-four day study.

NCT ID: NCT01821586 Completed - Clinical trials for Malnourished Children With Watery Diarrhoea

Modified ORS Solution for Severely Malnourished Children

Start date: April 2006
Phase: Phase 2
Study type: Interventional

Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths in developing counties. Physiologically, malnourished children excrete lower amounts of salts and water in diarrhoeal stools, and they also are unable to handle excessive salts and water load. Some times they are found to be hyponatraemic due to the shift of sodium inside the cells (inefficient Na+ /K+ pump), and fluids containing higher amounts of sodium (such as the standard ORS) may lead to further increase in the intracellular sodium, fluid overload and heart failure. They also have depleted in potassium stores in the body. Recently, the WHO recommended a special ORS formulation, known as ReSoMal, for management of diarrhoea in severely malnourished children that contains a lower amount of sodium (45mmol/L) and higher amount of potassium (40 mmol/L) than the standard WHO-ORS. It is felt that an ORS containing lower sodium and higher potassium concentration may be useful in correcting hypokalemia, and in lowering the risks of excess sodium and /or overhydration, in severely malnourished children with diarrhoea. The safety of ReSoMaL is, however, still in question due to the risk of hyponatraemia, including symptomatic hyponatraemia, especially in the treatment of severe watery diarrhoea due to Vibrio cholerae and ETEC where loss of sodium in the stool exceeds than that is contained in ReSoMal. Thus an ORS solution with modest concentration of sodium (75 mmol/L) and higher concentration of potassium (40 mmol/L) have been suggested for the treatment of diarrhoea in these children. To improve the efficacy of oral rehydration, in terms of reducing the severity of purging and diarrhoea duration, different approaches (changing the substrates/ reducing the sodium and glucose concentration and osmolarity) have been tried with limited success. Benefiber (partially hydrolysed guar gum), a soluble fiber if added to a ORS solution is expected to be fermented in the colon liberating short chain fatty acids (SCFAs). SCFAs stimulate sodium and water absorption from the colon, and they have trophic effect, act as a fuel source for the colonocytes, have antibacterial properties and stimulates the production commensal flora, thereby may enhance recovery from acute diarrhoea in severely malnourished children. The aims of our proposed study are to examine whether an ORS solution with a modest concentration of sodium will prevent the occurrence of hyponatraemia including symptomatic hyponatraemia, and also whether addition of benefiber will improve the efficacy of ORS solution. This will be a randomized, double blind, controlled clinical trial in 186 children with severe malnutrition and watery diarrhoea (62 in each of the three treatment groups) to compare the efficacy of (i) the currently recommended ORS with some modofication(Na+ 75 mmol/L and K40 momol/L and minerals-Zinc, copper and magnesium), (ii) ReSoMal (Na+ 45 mmol/L), (iii) Currently recommended ORS (Na+ 75 mmol/L, K 40 momol/L and added minerals) with added Benefiber (25 grams/L), in the treatment of acute watery diarrhoea in children with severe malnutrition