Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.

NCT00324285 | Completed Phase 3

• 1 other identifier: 2001-007
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhoea; Severe Malnutrition

Keywords

Diarrhoea; severe malnutrition; amylase resistant starch; ORS

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhoeal course and stool output.

Secondary Outcomes (4)

• Secondary

• Calorie intake per day

• Daily weight gain

• Time to attain 80% weight for height

Interventions

Amylase resistant starch added ORS DRUG

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• History of acute watery diarrhoea of \<72 hrs
• Either sex
• Age - 6 months to 60 months
• Some or severe dehydration
• Wt for Ht \<70% of NCHS median: with or without edema
• Dark field examination positive for Vibrio cholerae
• Consent

You may not qualify if:

• Bloody diarrhoea
• Severe infection (e.g. severe pneumonia, clinical sepsis, meningitis) 3.Those who received antibiotics/antimicrobial for the current illness

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Nestlé Foundation: collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Malnutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nur H Alam, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 11, 2006
• Study Start: July 1, 2001
• Primary Completion: June 30, 2005
• Study Completion: June 30, 2005
• Last Updated: November 28, 2017

Record last verified: 2006-05

Locations

BA (1)