Probiotic intervention to improve maternal gut health
Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia
This study is testing if a probiotic called Vivomixx can help improve gut health in pregnant women in certain countries to support better growth for their babies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Chandpur) |
| Trial ID | NCT06196450 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether the probiotic Vivomixx can positively influence maternal gut microbiota and alleviate environmental enteropathy, a condition that negatively impacts growth during the critical first 1000 days of life. The study focuses on pregnant women in specific regions of Bangladesh, Pakistan, Senegal, and Zambia, where environmental enteropathy is prevalent. By assessing the effects of Vivomixx, the trial aims to gather data that could inform larger-scale interventions aimed at improving birth outcomes and postnatal growth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 years or older in their first or early second trimester living in areas with high rates of environmental enteropathy.
Not a fit: Patients who have had recent gastrointestinal issues, chronic diseases, or those who have taken certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance maternal gut health, leading to improved growth and health outcomes for infants.
How similar studies have performed: Other studies have shown promise in using probiotics for gut health, but this specific approach targeting maternal health and environmental enteropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 years or older in the first trimester or early second trimester of pregnancy, living in defined geographical areas of Bangladesh (Matlab), Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal Exclusion Criteria: * Potential participants will not be enrolled if they: * have had diarrhea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days * 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 pallor (hemoglobin concentration \<8g/dl) * have any chronic disease, illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy * have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder) * have the plan to observe fast at any time during the intervention period * have the plan to leave the study area within the follow-up period * are included in any other intervention 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
Chandpur
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) — Chandpur, Bangladesh (Recruiting)
Study contacts
- Principal investigator: S. M. Tafsir Hasan, MBBS, MS — Nutrition Research Division, icddr,b
- Study coordinator: S. M. Tafsir Hasan, MBBS, MS
- Email: tafsir.hasan@icddrb.org
- Phone: (+88 02) 9827001-10
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.