View clinical trials related to Diarrhoea.
Filter by:Zinc deficiency has been found to be widespread among children in developing countries.Clinical and field studies have consistently observed an association between zinc deficiency and higher rates of infectious diseases, including skin infections, diarrhea, respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc deficiency on diarrheal disease alone, it is estimated correction of this deficiency could save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell membrane, and cellular function, leading to the understanding that it also plays a central role in cellular growth and in the function of the immune system. With zinc deficiency epithelial barriers are compromised and multiple components of the immune system malfunction. The obvious conclusion is that zinc deficiency results in diminished immunological competence that in turn leads to an increased risk for infectious diseases and greater severity of illnesses. Whether this is the case requires substantiation. A related, but more pragmatic question is the value added of zinc supplementation in addition to zinc treatment. The scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment at the time of a diarrhea episode. This is in accordance with recently revised WHO recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude there is no or minimal value added to continuing zinc as a dietary supplement in zinc deficient children following an acute episode? If there is added benefit, can this be explained by improvement in zinc levels and/or immune function? The aims of this study include:1. In children six to twenty-four months of age with an acute episode of diarrhea attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune response to zinc and to relate changes in immune function or zinc status to the occurrence of repeat infectious illnesses over a 9 month period of observation. 2a. In children six to twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to assess the impact of zinc supplementation on health services utilization and household expenditures for ACD, ARI and impetigo.
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.
Severe malnutrition is associated with a high rate of mortality, even when using the latest WHO recommendations. Watery diarrhea as observed in cholera is an additional vital risk to those children. The fragility of the children together with the complexity of the pathophysiology and the simplicity of the medical environment where the treatment is delivered are serious constraints for the development of new therapies. Dehydration is a special immediate risk in those children who already displayed altered body distribution of water with potassium, magnesium, zinc and other nutrient deficiency. Dehydration is also often associated with a decrease in appetite. In addition, the intestinal function is altered both by the infectious agent and the nutritional status of the child. Recommended therapy for those children comprises oral rehydration with ReSoMaL (modified ORS for use in severely malnourished children recommended by WHO), at a relatively low rate, with permanent monitoring; in addition, breastfeeding should not be interrupted and feeding with F100 (Milk based formula diet for use in severely malnourished children recommended by WHO) is recommended. Recently, amylase-resistant starch added to a standard WHO-ORS has been shown to reduce the duration and severity of adults with cholera. The rationale for using amylase-resistant starch was that when starch enters the colon it is metabolized by the bacteria. The short-chain fatty acids thus produced stimulate sodium absorption in the colon, just like glucose stimulates water absorption in the small intestine. In addition, this treatment would be of particular interest in malnutrition because short-chain fatty acids are specific energetic substrate for the colon.In the present project, we propose to test the hypothesis that addition of amylase-resistant starch to the already recommended treatment of severely malnourished children with cholera reduces the severity and duration of diarrhea; this could be achieved through the effect of short-chain fatty acids on colonic sodium absorption. In addition, a better recovery from malnutrition could be achieved through the energy provided by short-chain fatty acids to the colon and improved appetite through improved rehydration. Thus, the aim of the study is to measure the effect of amylase-resistant starch added to an already accepted treatment (with minimal changes) at the rehydration and rehabilitation phases of the treatment. A total of 210 children aged 6 mo to 60 mo will be studied in three groups : a) glucose based ORS and amylase-resistant starch; b) glucose based ORS without amylase resistant starch ; c) rice based ORS . The major outcome variables on the first phase (diarrhoeal duration and stool output), and second phase (food intake, weight gain) will be compared between the two treatment groups. The result of the study if found effective in reducing the duration of diarrhoea, enhance recovery from diarrhoea and malnutrition in severely malnourished children, will contribute to better case management of these children.
The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.