Could a probiotic protect pregnant women and their babies from gut damage?
NCT ID NCT07207434
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a probiotic called VE818 can reduce harmful bacteria in the gut and improve gut health in pregnant women. About 144 pregnant women in Bangladesh, Pakistan, Zambia, and Burkina Faso will take part. They will first receive an antibiotic (vancomycin) and then either VE818 or a placebo. The goal is to see if VE818 can lower levels of 11 specific harmful germs and help prevent gut problems that can lead to malnutrition and stunting in children.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mother and Child Health Research and Training Center, AKU
RECRUITINGMatiari, Sindh, 71000, Pakistan
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