Probiotics and oral vancomycin to improve gut health in pregnant women in Burkina Faso

Ability of the Probiotic VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: A Proof-of-Concept and Phase II Randomized Placebo-Controlled Trial in Bangladesh, Pakistan, Zambia, and Burkina Faso.

This study will test whether giving a probiotic called VE818 or a short course of oral vancomycin to pregnant women with intestinal pathogen markers can improve mothers' gut health and newborn outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Ghent (Academic / other)
• Locations: 1 site (Bobo-Dioulasso)
• Trial ID: NCT07134790 on ClinicalTrials.gov

What this trial studies

Pregnant women aged 18 or older at 13–17 weeks' gestation in the study catchment are screened for fecal pathogen markers and WASH risk, and eligible participants with two or more targeted bacterial pathogens are randomized into three arms (VE818 probiotic, placebo, or observation-only) with 48 women per arm. All participants receive WHO-recommended multiple micronutrient supplements during pregnancy, the probiotic and placebo arms are blinded, and the observation arm is unblinded. Women are followed to delivery, mother–infant dyads are sampled seven days after birth, and clinical and microbiologic outcomes are tracked through one month postpartum. The trial uses TAC-qPCR to identify pathogen carriage and measures clinical and biomarker endpoints related to environmental enteric dysfunction and birth outcomes.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 or older at 13–17 weeks' gestation who live in the local study area, have at least two of the specified fecal bacterial pathogens by TAC-qPCR, and meet the WASH-risk criteria.

Not a fit: Women without the targeted fecal pathogens, those enrolled outside the 13–17 week window, or those with contraindications to probiotics or antibiotics are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the interventions could reduce maternal EED, improve birth weight and early infant gut health, and help lower the risk of childhood stunting.

How similar studies have performed: Some small probiotic studies and observational work suggest maternal gut-targeted approaches may influence infant health, but randomized maternal probiotic or antibiotic interventions for EED are relatively novel with limited definitive success data.

Eligibility criteria

All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.

Inclusion criteria

1. Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \[GA\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent

   AND
2. Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.

   AND
3. Presence of any of the following WASH conditions -

1\. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing

Exclusion criteria

Potential participants will not be enrolled if they:

1. have MUAC ≥30 cm
2. are carrying more than one fetus (i.e., multiple pregnancy)
3. have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
4. have fever or an active infection
5. have taken antibiotics or probiotics in the preceding 14 days
6. have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
7. have severe anemia as determined using finger stick Hb \< 8 g/dl
8. have a history of chronic digestive disease
9. have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
10. have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)
11. have known drug hypersensitivity/allergy/intolerance
12. have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
13. are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation
14. have a plan to observe fast any time during the intervention period
15. have a plan to leave the study area within the follow-up period
16. are participating in any other interventional trial
17. belong to a household from which another woman is already enrolled in the study

but may be enrolled if/when these disqualifiers have expired.

Where this trial is running

Bobo-Dioulasso

• Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique — Bobo-Dioulasso, Burkina Faso (Recruiting)

Study contacts

• Principal investigator: Trenton M. Dailey-Chwalibóg, M.P.H., Ph.D. — Ghent University and Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
• Study coordinator: Trenton M. Dailey-Chwalibóg, M.P.H., Ph.D

Conditions Environmental Enteric Dysfunction