View clinical trials related to Diarrhea.
Filter by:A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, bifidobacterium and streptococcus species. The supplementation of probiotics to infants may also have a prophylactic effect against acute diarrhoeal diseases. In the present proposal, we plan to examine if daily intake of a probiotic beverage, which includes 15 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea in Kolkata. OBJECTIVES Primary objectives: 1. To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in children 2. To assess the impact of probiotics on nutrition and growth of the children Secondary Objectives: 1. Reduction in duration, frequency of diarrhoea 2. Identification of pathogens causing diarrhoea 3. Examination of faecal microflora STUDY DESIGN It will be a double blind randomized controlled field trial involving 4000 children aged between 1 and 5 years in an urban slum of Kolkata, India. The 4000 children will be identified through demographic survey. The study will be double blinded where the study arm will receive Probiotic drink, which includes 15 billion probiotic Lactobacilli, one bottle (65ml) daily (under supervision of a Health Worker) for 12 weeks and the control arm will receive a similar drink without the lactobacilli (Nutrient drink) daily for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 2000 children each. All the children under the study will be visited daily by a health worker who will supervise intake of Probiotic drink or Nutrient drink by the children. All the children will be followed up daily for 24weeks for identification of acute diarrhoea cases.
Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied. Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year. Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.
This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge. The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
This is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.
The objective of this study was to determine the effectiveness and cost-effectiveness of a package of interventions to support health workers in Benin (in West Africa) who had been trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines intended to improve the treatment of childhood illnesses).
Medical literature has dealt with various perspectives of probiotic therapy - prevention of antibiotic associated diarrhoea, Clostridium difficile, etc. However, there have been no published results which can provide a basis for a generalized recommendation or discouragement of probiotic use among various groups of hospitalized patients. The hypothesis is that the benefit in probiotic therapy in the admitted patient is by far larger than the actual cost of therapy. This assumption is probably true for all admitted patients and for patients on antibiotic therapy in particular.
Title: Impact of daily zinc supplementation to infants born with low birth weight on mortality and severe disease requiring hospitalization Background: Zinc supplementation was shown to prevent diarrhea and pneumonia in 6 month to 3 year old children. Little is known about the impact of zinc supplementation of low birth weight (LBW) babies during first 6 months of life. Objective: The objectives were to determine the impact of daily zinc administration at 1RDA (5 mg) of elemental zinc to LBW infants on severe morbidity requiring hospitalization and on all cause mortality. Design: In a double blind randomized placebo controlled trial 2012 hospital-born infants with a birth weight <2500 g were randomly assigned to receive zinc or placebo for 6 months. Zinc group received 5 mg elemental zinc as acetate daily from 4 weeks age. Cause specific hospitalization deaths, episodes of diarrhea, acute respiratory infections, other illness, visits to health care providers and hospital OPDs were ascertained by in-depth interview and from documents like prescriptions, hospital tickets, medicine cartons at 3 and 6 months of age. Results: Number of infants with one or more diarrhea episodes was less by 17% (95% CI: 1% to 35%) in the zinc group but the numbers for ARI were similar in the two groups. The hospitalization rates due to all causes or diarrhea or ARI were similar in the two groups. Twelve in the zinc group and 9 in the placebo group died during 4 weeks to 6 months (p=0.36). We observed no significant difference for gain in weight and length at 3 months and 6 months between the groups. In a subgroup of infants the mean serum zinc concentration in the zinc group was 27% higher (p=0.004) than the placebo group. Conclusion: Hospital born, low birth weight infants do not seem to derive worthwhile benefit from daily zinc supplementation of recommended dietary allowance for zinc in terms of morbidity and growth during first six months of life.
For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
With the long-term public health goal of developing an effective micronutrient supplementation program to improve child health by improving iron and zinc status and decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we seek to determine the most efficacious method of decreasing childhood morbidity and mortality due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and determining if this interaction can be minimized by separate administration of iron and zinc supplementation.