MDCF-2 prototype with four complimentary food ingredients without powdered milk (rationale: lead with evidence from the recently completed pre-POC clinical trial of promoting growth promoting microbiota and positive effects on growth).

Rice-lentil based RUSF (rationale: reference standard of care for post-SAM, MAM; based on knowledge of its effects on child growth and the gut microbiota)

Microbiota

Complementary Food

Nutrition

MDCF prototype with four complimentary food ingredients without powdered milk (rationale: lead with evidence from the recently completed pre-POC clinical trial of promoting growth promoting microbiota and positive effects on growth

Microbiota Directed Complementary Food-2

Ready to Use Supplementary Food

Icddr,B

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

Rate of weight gain of the enrolled participants

Information about all proteins that are made in blood, other body fluids, or tissues, at certain times.It will be assayed by Somalogic scan

Refers to having a disease or a symptom of disease. It will be assessed by taking morbidity data

bacterial species whose proportional representation define a healthy gut microbiota as it assembles during the first two postnatal years of life. 'microbiota-for-age Z-score' compares development of a child's fecal microbiota relative to healthy children of similar chronologic age.

International Centre for Diarrhoeal Disease Research, Bangladesh

Washington University School of Medicine

MDCF2 with four complementary food ingredients (rationale: lead with evidence from Pre-POC clinical trials to optimize lead microbiota-directed complementary food prototypes for their ability to repair microbiota immaturity and positive effects on growth)

Rice-lentil based RUSF (rationale: reference standard of care for MAM; based on knowledge of its effects on the gut microbiota or microbiota immaturity)

Microbiota Directed Complementary Food (MDCF)

Ready to Use Supplementary Food (RUSF)

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

Microbiota-directed Complementary Food (MDCF) Trial

Information about all proteins that are made in blood, other body fluids, or tissues, at certain times. It will be assayed by Somalogic scan.

Refers to having a disease or a symptom of disease. It will be assessed by taking morbidity data.

Bacterial species whose proportional representation define a healthy gut microbiota as it assembles during the first two postnatal years of life.'Microbiota-for-age-Z-score' compares development of a child's fecal microbiota relative to healthy children of similar chronologic age.

Test 3 prototype MDCFs and the current rice-lentil RUSF standard of care for MAM to establish the effect size of each on MAZ repair in a 4 week 2x /day intervention, with a 2 week post-intervention phase to assess durability of MDCF-induced changes in the microbiota.

Select most efficacious MDCF from study 1 and compare with 2 additional MDCF prototypes using the same design used in study 1.

Select lead MDCF from studies 1, 2 and conduct final 'bake-off' vs current RUSF and also examine the impact of 1x vs 2x per day administration with a 4 week post-intervention period to provide additional information on the durability of MDCF-sponsored changes in the microbiota.

In order to construct a library of gut microbiota of healthy growing children of the same community, one spot fecal sample (1-2 gm) and spot blood sample (2 mL) will be collected from 30 children each who would be aged 12-18 months of either sex, having WLZ and LAZ : >-1

Pre Proof of Concept Clinical Trial

For Study 1: Investigators will test 3 prototype MDCFs and the current RUSF standard of care for MAM to establish the effect size of each on MAZ repair in a 4 week twice daily intervention, with a 2 week post-intervention phase.
Study 2: From study 1 Investigators will select most efficacious MDCF and compare with 2 additional MDCF prototypes to establish the effect size of each on MAZ repair in a 4 week twice daily intervention, with a 2 week post-intervention phase.
Study 3: Investigators will select the lead MDCF from study 2 and examine the effects between the final MDCF versus current RUSF and also examine the impact dispensing of the lead MDCF once versus twice per day with a 4 week post-intervention period.

Mirpur

'Pre-Proof of Concept (Pre-POC)' Clinical Trials to Optimize Lead Microbiota-directed Complementary Food (MDCF) Prototypes for Their Ability to Repair Microbiota Immaturity and Establish Their Organoleptic Acceptability

Microbiota Directed Complementary Food (MDCF) Translational Trial

MAZ Score=(microbiota age-median microbiota age of healthy children of same chronologic age)/(standard deviation of microbiota age of healthy children of the same chronologic age)

indole acetic acid/opkast

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)

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

'Pre-Proof of Concept (Pre-POC)' Clinical Trials to Optimize Lead Microbiota-directed Complementary Food (MDCF) Prototypes for Their Ability to Repair Microbiota Immaturity and Establish Their Organoleptic Acceptability

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