Probiotic treatment during pregnancy to improve maternal gut health
Ability of 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 will see if a short course of oral vancomycin followed by the probiotic VE818 helps improve gut health in pregnant women who carry certain gut bacteria.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Matiari, Sindh) |
| Trial ID | NCT07207434 on ClinicalTrials.gov |
What this trial studies
Pregnant women in the 13–17 week gestational window are screened for specific enteric bacteria and WASH risk factors and, if eligible, will be enrolled and followed at the Matiari, Pakistan site. About 144 women are enrolled and 96 randomized in a double-blind design to receive 5 days of oral vancomycin, a short washout, then either VE818 or placebo for two weeks, with daily follow-up for 21 days to track adherence and adverse events. Investigators collect blood, urine, vaginal swabs, and stool (including CapScan samples) before and after treatment to measure changes in gut pathogens and biomarkers of intestinal inflammation and barrier function. The trial uses community-based recruitment through a demographic surveillance system and involves collaborators with regional and international research partners.
Who should consider this trial
Good fit: Women aged 18 or older at 13–17 weeks gestation who live in the defined study area and have stool testing positive for at least two of the specified bacterial targets and meet the listed WASH exposure criteria are the intended participants.
Not a fit: Women who are not colonized with the targeted enteropathogens, are outside the 13–17 week enrollment window, or have contraindications to vancomycin or probiotic products are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce intestinal inflammation and improve maternal gut barrier function, potentially improving maternal nutrition and offspring outcomes.
How similar studies have performed: Some probiotic and microbiome-modulation studies have shown modest improvements in gut biomarkers, but using an antibiotic 'reset' followed by VE818 in pregnant women is a relatively novel approach and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 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 * 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. * 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: * have MUAC ≥30 cm * are carrying more than one fetus (i.e., multiple pregnancy) * have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days * have fever or an active infection * have taken antibiotics or probiotics in the preceding 14 days * have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days * have severe anemia as determined using finger stick Hb \< 8 g/dl * have a history of chronic digestive disease * have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder) * have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.) * have known drug hypersensitivity/allergy/intolerance * have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy * 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 * have a plan to observe fast any time during the intervention period * have a plan to leave the study area within the follow-up period * are participating in any other interventional trial * 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
Matiari, Sindh
- Mother and Child Health Research and Training Center, AKU — Matiari, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Asad Ali Syed, MPH — Aga Khan University
- Study coordinator: Asad Ali Syed, MPH
- Email: asad.ali@aku.edu
- Phone: +92 2134864233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.