Background (brief): 1. Burden: A total of 52 million children under 5 are suffering from acute malnutrition globally, of whom 33 million suffer from moderate acute malnutrition (MAM). In Bangladesh, around 2 million children suffer from MAM. In absolute numbers, according to Bangladesh Demographic Health Survey 2014, 26%, 25% and 17% of children aged less than two years are stunted, underweight and wasted respectively.1 2. Knowledge gap: We have already demonstrated that children with acute malnutrition have immature gut microbiota that is partially corrected with treatment. Children with MAM have an increased risk of mortality, infections and impaired physical and cognitive development compared to well-nourished children. Although the global caseload of MAM is much greater than that of SAM, the condition has not received the same level of attention or priority. Through our previous and ongoing research we now know about the members of the gut microbiota that can promote growth in children and also about certain food ingredients that promote the proliferation of such beneficial microbiota. However, this knowledge needs to be applied on a large scale community-based clinical trial. 3. Relevance: The rationale for this study is to assess whether long-term administration of complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (MDCF-2), as identified in our Pre-POC trial, is able to produce predictable changes in the microbiota of Bangladeshi children with Post-SAM MAM as well as in their nutritional status. We would now like to do a community-based clinical trial of this potential MDCF-2 in the management of children with Post-SAM MAM. Hypothesis (if any): Complementary foods made of locally available food ingredients that stimulate the proliferation of growth promoting gut microbiota (MDCF-2) will improve clinical outcomes. 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 Methods: We will conduct a proof of concept (POC) clinical trial in 12-18 months old children with post-SAM MAM (Weight-for-Length Z-score, WLZ \<-2 to -3) over the course of approximately two years. This study will be undertaken at Mirpur area of Dhaka city and in Kurigram. We will produce MDCF-2 at the icddr,b Food Processing Laboratory in sufficient quantities for the trial. This formulation is matched for energy density and micronutrient content of ready to use supplementary food (RUSF) used for MAM. It itself is not a ready-to-use food but is rather a cooked food made of locally available food ingredients (chickpea, green banana, peanut, soybean flour) which have been found to enhance growth promoting members of the gut microbiota in children. We will test MDCF-2 and the current RUSF standard of care for Post SAM MAM to see the effect on growth, proteomics and metabolomics of an intervention for 12 weeks, with a 4-week post-intervention phase. Outcome measures/variables: * 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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in Ponderal growth
Timeframe: At the enrollment (day1), every day during acute phase and nutritional rehabilitation phase, every 15 days during the 3 months of intervention phase and at the end of 1 month of follow up phase by anthropometry
Change in Liner growth (LAZ)
Timeframe: At the enrollment (day1), every week during the acute phase and nutritional rehabilitation phase, every 15 days during the 3 months of intervention phase and at the end of 1 month of follow up phase by anthropometry
Change in Proteomic profile
Timeframe: A total of 4 plasma samples will be collected, at enrollment, prior to 3 months of intervention, end of first month of intervention and just after the completion of intervention.
Change in Morbidity
Timeframe: Data will be collected every day from enrollment, during the acute and rehabilitation phase, 3 months of intervention phase and once at the end of 1 month of follow up phase.
Change in Microbiota-for-Age Z (MAZ) score
Timeframe: At enrollment, every alternative day during the stabilization phase, once during the nutritional rehabilitation phase, weekly during the first month of intervention, at the end of 2nd and 3rd months of intervention & at the end of 1 month of follow up.