Probiotic treatment for improving gut health in pregnant women in Senegal
Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Senegal
This study is testing whether a probiotic treatment can help improve gut health in pregnant women in Senegal who are dealing with a condition that can affect their children's growth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Pasteur de Dakar Academic / other |
| Locations | 1 site (Guédiawaye, Dakar) |
| Trial ID | NCT05501470 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of probiotics on Environmental Enteric Dysfunction (EED) in pregnant women living in Senegal. EED is a condition that negatively impacts gut health and is linked to childhood stunting, which affects millions of children globally. The study will compare the probiotic treatment to a placebo to assess its efficacy in improving gut microbiota and overall health. Participants will be monitored for safety and effectiveness over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over the age of 18 residing in the Guediawaye district of Senegal.
Not a fit: Patients who have had diarrhea or taken antibiotics or probiotics in the past 14 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve gut health in pregnant women, potentially reducing the risk of stunting in their children.
How similar studies have performed: Other studies have shown promising results with probiotics in improving gut health, but this specific approach in pregnant women with EED is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women over the age of 18, living in Guediawaye district, Senegal Exclusion Criteria: * • 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 non-steroidal anti-inflammatory drugs in the preceding 14 days * have any illness which in the opinion of the investigator will complicate 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 a plan to leave the study area within the follow-up period but may be enrolled if/when these disqualifiers have expired.
Where this trial is running
Guédiawaye, Dakar
- Centre de santé de Wakhinane — Guédiawaye, Dakar, Senegal (Recruiting)
Study contacts
- Principal investigator: Yakhya Dieye, PhD — Institut Pasteur de Dakar
- Study coordinator: Billo TALL, MD
- Email: billo.tall@pasteur.sn
- Phone: +221 77 535 81 35
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.