Community-based Clinical Trial With Microbiota Directed Complementary Foods (MDCFs) Made of Locally Available Food Ingredients for the Management of Children With Post-severe Acute Malnutrition Moderate Acute Malnutrition (Post-SAM MAM)
Microbiota Directed Complementary Food (MDCF) Post-SAM MAM Trial
Other study identifiers
Sponsor study identifier
interventional
124
1 country
1
Study Start
November 1, 2018
Actual (reported)Primary Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief Summary
Background (brief):
- Ponderal growth (rate of weight gain as the primary outcome variable), measured at different time points by anthropometry
- Linear growth, measured at different time points by anthropometry
- Proteomic profile, assayed by DNA aptamer based SOMAlogic scan
- Morbidity, assessed by daily records
- Change in microbiota-for-age Z score Hypothesis to be tested: Complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (MDCF-2) will improve nutritional outcomes. Specific Objectives To investigate the efficacy of complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (Microbiota Directed Complementary Food: MDCF-2) in (i) promoting repair of microbiota immaturity (ii) promoting proliferation of beneficial bacteria (iii) improving both linear and ponderal growth in children with Post-SAM MAM (iv) improving the metabolomic profile of children with Post-SAM MAM
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 124 participants
- Study completion date
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
November 1, 2018
Actual (reported)First Submitted
June 23, 2019
Actual (reported)First Posted
July 11, 2019
Actual (reported)Primary Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- March 9, 2021
- Status Verified
- January 2021
- Last Update Submitted
- March 8, 2021