None listed
Conditions
Interventions
Intervention1: (MDCF)Microbiota-directed complementary foods: 1) Components:
MDCF (g/100g)(
Bengal gram dal flour- 13g,
Peanut paste- 13g,
Soybean flour (brown)- 11g,
Green Banana powder- 15 g,
Sugar
Sponsors
Christian Medical College (CMC), Vellore
Eligibility
Inclusion criteria
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 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 2. Anthropometric scores (WLZ above -1SD) 3. Willing to stay in the study area for 2 years
Exclusion criteria
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))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Acceptability of the food supplements (MDCF and RUSF) amongst study participants and caregivers and compliance to the intervention. 2.Feasibility of collection, transport and storage of fecal samplesTimepoint: 1. At week 2 to Week 6 from enrollment 2. during overall study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Enteropathogenic burden (estimated using PCR-based analysis of the fecal samples)Timepoint: end of study;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;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 | — |
Countries
India
Contacts
Public ContactDr Gagandeep Kang
KEM Hospital Research center, Pune
Outcome results
None listed