Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.
Status:
Completed
Trial end date:
2005-06-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh