Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.

This study has been completed.
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00324285
First received: May 10, 2006
Last updated: March 20, 2013
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Diarrhoea
Severe Malnutrition
Drug: Amylase resistant starch added ORS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children With Watery Diarrhoea Due to Vibrio Cholerae

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Duration of diarrhoeal course and stool output. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary
  • Calorie intake per day
  • Daily weight gain
  • Time to attain 80% weight for height

Estimated Enrollment: 180
Study Start Date: July 2001
Estimated Study Completion Date: October 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Bloody diarrhoea
  2. Severe infection (e.g. severe pneumonia, clinical sepsis, meningitis) 3.Those who received antibiotics/antimicrobial for the current illness
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00324285

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Nestlé Foundation
Investigators
Principal Investigator: Nur H Alam, MD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00324285     History of Changes
Other Study ID Numbers: 2001-007
Study First Received: May 10, 2006
Last Updated: March 20, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Diarrhoea
severe malnutrition
amylase resistant starch
ORS

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014