How maternal malnutrition and poor WASH shape infant gut microbiome development

Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)

This project will follow pregnant women and their babies in Zimbabwe to see if maternal malnutrition and poor water, sanitation and hygiene change the baby's gut microbiome and gut health.

Quick facts

• Study type: Observational
• Enrollment: 368 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Zimbabwe (other)
• Locations: 1 site (Harare)
• Trial ID: NCT07195006 on ClinicalTrials.gov

What this trial studies

This observational cohort enrolls malnourished and matched well-nourished pregnant women in Harare and follows mother–infant pairs for up to three years to document microbiome trajectories and gut health. Cases (MUAC ≤23 cm) and controls (MUAC 25–35 cm) are recruited at ≥20 weeks' gestation with repeated collection of stool, clinical measures, WASH assessments, and breastfeeding samples. The study will measure markers of environmental enteric dysfunction, intestinal inflammation, and infant growth and neurodevelopment. Analyses will link maternal and household exposures (nutrition, WASH, maternal stress) to infant microbiome changes and health outcomes.

Who should consider this trial

Good fit: Pregnant women aged 18 or older at ≥20 weeks' gestation who plan to remain in the study area for three years, are at least 150 cm tall, and meet the nutritional criteria (MUAC ≤23 cm for cases or MUAC 25–35 cm for controls) are ideal candidates.

Not a fit: Women under 18, those earlier than 20 weeks' gestation, those planning to move away, or those with acute or chronic conditions judged by investigators to interfere with participation may not receive benefit because they are ineligible or cannot complete follow-up.

Why it matters

Potential benefit: If successful, this work could identify early-life biological and environmental targets to reduce malnutrition, improve gut health, and support better growth and development in infants.

How similar studies have performed: Previous observational studies have linked early-life microbiome patterns to malnutrition and EED, but interventional trials have had mixed results and comprehensive mother–infant data from Sub-Saharan Africa remain limited.

Eligibility criteria

Inclusion Criteria for Cases:

* MUAC ≤23 cm in pregnancy
* ≥18 years' old
* At least 20 weeks' gestational age
* Height ≥150 cm
* Planning to be staying in the study area for the next 3 years
* Willing to participate and comply with all study requirements and procedures.

Any pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study

Inclusion criteria for Controls

* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm
* Haemoglobin level of ≥11g/dL
* ≥18 years' old
* At least 20 weeks' gestational age
* Height ≥150 cm
* Planning to stay in the study area for the next 3 years

Exclusion Criteria

* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)
* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.

Where this trial is running

Harare

• University of Zimbabwe — Harare, Zimbabwe (RECRUITING)

Study contacts

• Principal investigator: Kerina Duri, Phd — University of Zimbabwe
• Study coordinator: Kerina Duri, PhD

Conditions: Malnutrition Pregnancy, Malnutrition in Children, Malnutrition, Environmental Enteric Dysfunction, Gut Dysbiosis, Gut Permeability, Gut Inflammation, Diarrhea Infectious, Maternal Stress