Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal ( PROFE-Sen )

Phase 2

• Conditions: Digestive System; Pregnancy and Childbirth

• Registration Number: PACTR202310762132359
• Lead Sponsor: Institut Pasteur Dakar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-22
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Any pregnant woman in the second trimester of pregnancy (confirmed by ultrasound)
• Adult (18 years old)
• living in defined geographical areas of Guediawaye
• Full understanding and consent agreement to participate in protocol as planned

Exclusion Criteria

• Had diarrhea, defined as the release of three or more loose stools per 24 hours in the previous 14 days.
• Have taken antibiotics or probiotics in the previous 14 days
• Have taken non-steroidal anti-inflammatory drugs or corticosteroids in the previous 14 days
• Have hemoglobin <8g/dl
• Have multiple pregnancies
• Have a disease that, in the investigator’s opinion, would complicate the assessment of safety or efficacy.
• Have a gastrointestinal contraindication to ingesting a capsule (known or suspected gastrointestinal obstruction, stenosis, fistula, gastroparesis or any swallowing disorder).
• Have plans to leave Guédiawaye during the follow-up period
• Included in any other interventional trial
However, they may be included in the trial when these criteria have expired.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in inflammation and epithelial damage in pregnant women with environmental enteropathy : percentage change (mean, unweighted) in a multiple panels of biomarkers between baseline and last sample collected after 56 days of treatment, compared to a control group.