'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

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Mar 14, 2017

Keywords

ClinConnect Summary

Investigators will conduct 3 Pre-POC studies among 12-18 month old children with MAM (WLZ \<-2 to -3) and stunting (LAZ \<-2 to -3) over the course of approximately two years.

Study design: Randomized controlled intervention trial.

Study site: This study will be conducted at Bauniabadh, Mirpur in Dhaka city, which is a peri-urban slum area.

Study participants: The study participants will be 12-18 months old children of either sex with MAM (WLZ: \<-2 to -3) and stunting (LAZ: \<-2 to -3).

Initial screening and enrolment: Children will be screened and enrolled by household survey in secti...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All of the following criteria must be met for a study participant to be eligible to participate in the study -
• • Parent(s) willing to sign consent form
• • Child age 12-18 months and no longer exclusively breast fed
• • WLZ between \<-2 and -3; LAZ: between \<-2 and -3
• • Parent(s) willing to bring child to the feeding centre twice daily for 4 weeks for nutritional therapy and provide weekly fecal samples from their child for the duration of the study. The informed consent document will explicitly request permission to use the collected fecal samples for future studies, including but not limited to culturing component bacterial strains.
• Exclusion Criteria:
• • Medical conditions: Children with tuberculosis (diagnosis based on WHO 2014 guidelines which have been incorporated in the national TB control guidelines of Bangladesh)12 or any congenital/acquired disorder affecting growth i.e. known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy.
• • Febrile illness or antibiotic use within the last 30 days
• • Receiving concurrent treatment for another condition
• • Any known history of or screened positive for clotting disorders or severe anaemia (\<8mg/dl)
• • Failure to obtain informed written consent from parents or caretakers