View clinical trials related to Diarrhea.
Filter by: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.
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.
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?
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.
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.
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
An Ontario-wide study to identify best strategies to promote uptake of high quality, expert developed Clinical Pathways (CPs) within Emergency Departments. The investigators will work with 16 Community EDs across Ontario to i) tailor an implementation strategy that works for each ED, ii) assist with the implementation of one pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact on health professionals, patient outcomes and economic costs. The investigators will conduct a 3.5 - year mixed methods health services research project with four study objectives: 1) to design a theory-based and knowledge user-informed intervention strategy to successfully implement two provincial pediatric emergency clinical pathways into practice in community Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to conduct an economic analysis to evaluate implementation costs and benefits.
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children
This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 39 healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in the children. This study will require volunteers to stay in the research facility for several nights for the first dose; they will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of milk ingredients. Aim: To study whether a milk protein concentrate rich in phospholipids improves the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks intervention with a milk protein concentrate rich in phospholipids in healthy subjects of 18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose will be 1010 CFU). Before and after infection, an online diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The diary will also be used for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers and to verify dietary calcium intake. Saliva is sampled three times before and after infection to quantify immune system markers. Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight.