Elimination of malnutrition using Microbiota-directed complementary foods in children with moderate malnutritio

Not Applicable

Registration Number: CTRI/2023/01/048716

Lead Sponsor: Christian Medical College (CMC), Vellore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 630

Inclusion Criteria

INTERVENTIONAL COHORT:

1.Children aged 6-18 months of either gender and no longer exclusively breastfed

2.Weight to length Z (WLZ) score <-2 to -3 without bilateral pedal edema at the time of randomization (for MAM children)

3.Parent(s) willing for study participation and aid in following study procedures

4.Agree to remain in the study area for the study duration

HEALTHY COHORT:

1. Age between 90 days to 119 days (3 to < 4 months)

2. Anthropometric scores (WLZ above -1SD)

3. Willing to stay in the study area for 2 years

Exclusion Criteria

INTERVENTIONAL COHORT:

1.Any ongoing fever or medical condition persisting for >last 14 days or requires hospitalization

2.Any congenital/acquired disorder affecting growth

3.History of soy, milk protein or peanut allergy

4.Severe pallor on examination

5.Antibiotic use (within last 15 days before the onset of intervention)

6.Ongoing maternal antibiotic usage for breastfeeding infants

7.Receiving concurrent treatment for another condition

8.Failure to obtain informed written consent from parents/guardians

9.Any other condition that in the opinion of the study investigator serves as an exclusion

Note: Criteria No 1, 4, 5,7 will be temporary exclusion criterion, children will be eligible for inclusion if they are not having any medical conditions, severe pallor, antibiotic use on any concurrent treatment for last 15 days from the day of enrolment.

HEALTHY COHORT:

1. No history of antibiotic consumption in the past 15 days (temporary exclusion)

2. History of any medical illness in the past 15 days (temporary exclusion)

3. Any medical condition persisting for >last 14 days prior to enrolment or requires hospitalization (temporary exclusion))

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Acceptability of the food supplements (MDCF and RUSF) amongst study participants and caregivers and compliance to the intervention. <br/ ><br>2.Feasibility of collection, transport and storage of fecal samplesTimepoint: 1. At week 2 to Week 6 from enrollment <br/ ><br>2. during overall study period.

Secondary Outcome Measures

Name	Time	Method
Enteropathogenic burden (estimated using PCR-based analysis of the fecal samples)Timepoint: end of study;Metabolic markers: Plasma proteomic profile (including mediators of bone growth and ossification, proteins associated with ponderal growth, and CNS development).Timepoint: At week 2 and week 6 from enrollment;Microbiota for age Z-score (MAZ).Timepoint: At week 0 to week 8 except week 7 for the interventional cohort and every month of healthy cohort;Weight-for-length z-score (WLZ), weight-for-age z-score (WAZ), length-for-age z-score (LAZ) and mid-upper arm circumference (MUAC) at the end of the study.Timepoint: At week 8 from enrollment