Status:
UNKNOWN
Community-based Clinical Trial With Microbiota-directed Complementary Foods (MDCFs) Made of Locally Available Food Ingredients for the Management of Children With Primary Moderate Acute Malnutrition
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Microbiota
Complementary Food
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
Background (brief): Burden: A total of 52 million children under 5 are suffering from acute malnutrition globally, of whom 33 million have moderate acute malnutrition (MAM). In Bangladesh, more than ...
Detailed Description
Background: Moderate acute malnutrition (MAM), a major global health problem, is defined as wasting (i.e. weight-for-height between \< -2 and -3 Z-scores of the WHO Child Growth Standards) and/or mid...
Eligibility Criteria
Inclusion
- Parent(s) willing to sign consent form
- Child age 12-18 months and no longer exclusively breast fed
- WLZ (\<-2 to -3) without bilateral pedal edema at the time of randomization
- Parent(s) willing to bring the child to the feeding center twice daily for 4 weeks for nutritional therapy, once daily for next 4 weeks and provide feeding once daily at home for 4 weeks and twice daily for next 4 weeks.
- The informed consent document will explicitly request permission to use the collected fecal samples for future studies, including but not limited to culturing component bacterial strains
Exclusion
- Medical conditions: Children with tuberculosis (diagnosis based on WHO 2014 guidelines which have been incorporated in the national TB control guidelines of Bangladesh). The guidelines depend upon the following five diagnostic principles (three out of five should be positive): 1. Specific symptoms of TB, 2. Specific signs, 3. Chest X-ray, 4. Mantoux test, and 5. History of contact. 10 or any congenital/acquired disorder affecting growth i.e. known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy
- Antibiotic use within the last 15 days
- Receiving concurrent treatment for another condition
- Severe anemia (\<8mg/dl) will be assessed by Hemocue (Model no. Hemocue Hb 301)
- Failure to obtain informed written consent from parents or caretakers
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2021
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04015999
Start Date
November 1 2018
End Date
June 28 2021
Last Update
July 21 2020
Active Locations (1)
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1
Icddr,B
Dhaka, Bangladesh, 1212