The Maternal EED Study

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

January 2, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Environmental Enteric Dysfunction (EED)MalnutritionWomen of Reproductive AgeGut MicrobiotaBalanced Energy Protein (BEP)
Interventions
DIETARY_SUPPLEMENT

Microbiota-directed balanced energy protein (MD-BEP)

Prototypes for nutritional interventions that are composed of locally available, affordable, culturally acceptable complementary foods commonly consumed in Bangladesh have recently been developed.

DIETARY_SUPPLEMENT

Ready-to-use supplementary food-balanced energy protein (RUSF-BEP)

RUSF-BEP is composed of rice, lentil, sugar, soybean oil, and skimmed milk powder mixed with vitamin-mineral premix. MD-BEP is composed of chickpea flour, peanut flour, soy flour, green banana pulp, sugar, soybean oil, and vitamin-mineral premix. The results from previous studies support the notion that repair of impaired gut microbial community development could represent a new therapeutic concept for restoring healthy growth. RUSF-BEP will be given to one arm of low-BMI women of reproductive age and low-BMI pregnant women.

PROCEDURE

Esophagogastroduodenoscopy (EGD)

Aim 1A consists of performing EGD to women with low-BMI and normal BMI women with function dyspepsia. In order to enroll 30 participants with normal duodenal mucosal histology, we are planning to perform EGD on 100 healthy women (BMI 20-24.9 kg/m2) of childbearing age who have been referred for evaluation of functional dyspepsia. Undernourished low-BMI (\<18.5kg/m2; 18-35 years) women of childbearing age will be enrolled from Bauniabadh and adjacent slum area of Mirpur, Dhaka and EGD will be performed among 60 women. A total of 6-8 biopsy samples from SI and a dry duodenal aspirate will be collected for biopsy, histochemical and immunocytochemical analysis.

BEHAVIORAL

Counselling and follow-up

Normal BMI pregnant women will be counseled and followed up as per standard guidelines and will be provided routine antenatal care.

Trial Locations (1)

1212

RECRUITING

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka

All Listed Sponsors
collaborator

Washington University School of Medicine

OTHER

collaborator

Bangladesh Specialized Hospital

UNKNOWN

collaborator

Sheikh Russel National Gastroliver Institute & Hospital

UNKNOWN

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER