Microbiota-directed complementary foods to treat children with moderate acute malnutrition in the first two years of life – Open label Randomized controlled Pre-proof of Concept (MDCF prePOC) study - MDCF prePOC

Christian Medical College (CMC), Vellore0 个研究点目标入组 630 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•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

•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))

发起方

Christian Medical College (CMC), Vellore