Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal

NCT05501470 | Recruiting Phase 2 DMC

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 were stunted, accounting for 22% of stunting globally. Stunting has short- and long-term consequences of increased morbidity and mortality, impairment of neurocognitive development , impaired responses to oral vaccines, and increased risk of non-communicable diseases. Stunting is partly driven by Environmental Enteric Dysfunction (EED), an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED may help explain why nutritional supplementation either during pregnancy or early childhood has minimal value in correcting childhood stunting. Probiotics may serve to overcome the problem of EED through all mechanisms of pathogenicity, by providing additional bacteria that may help in intestinal decolonization of pathogenic microorganisms (changing the microbiological niche), promoting epithelial healing, improving nutrient absorption, and restoration of an appropriate immune balance between tolerance and responsiveness. This trial will explore the conceptual framework, that a well known probiotic, that can improve the composition of the gut microbiota, can reduce biomarkers of intestinal inflammation and gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.

Conditions

Environmental Enteric Dysfunction

Keywords

Gut health; gut microbiota; Senegal; probiotics; Vivomixx; VSL3

Outcome Measures

Primary Outcomes (1)

• Change in inflammation and epithelial damage in pregnant women with environmental enteropathy

  Percentage change (mean, unweighted) in a multiple panel of biomarkers between baseline and last sample collected after 56 days of treatment, compared to control group.

  Day 0 (screening) - Day 56

Secondary Outcomes (6)

• Change in enteropathogen colonisation

  Day 1 - Day 56

• Impact on the structure and function of the microbiome

  Day 1 - Day 56

• Change in permeability

  Day 1 - Day 56

• Impact of the host metabolome in pregnant woman

  Day 1 - Day 56

• Rate of weight gain in the 2nd trimester of pregnancy

  Day 0 (screening) - Day 56

Other Outcomes (1)

• CapScan success rate in delivering an assessment of the microbiome

  Day 1 and Day 56

Study Arms (2)

Probiotic

EXPERIMENTAL

Participant in the treatment arm will receive a daily dose of the probiotic for 8 weeks.

Drug: Probiotic; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participant in the control arm will receive a daily dose of a placebo for 8 weeks.

Drug: Placebo; Device: CapScan®

Interventions

Probiotic DRUG

Probiotic

Probiotic

Placebo DRUG

Placebo

Placebo; Probiotic

CapScan® DEVICE

The only non-standard sample collection instrument is the CapScan® device. The CapScan Collection Capsule ("Capsule") is a non-invasive device that collects gastrointestinal samples along the GI tract that are then analyzed outside the body. Samples collected by the Capsule will be expressed, then undergo DNA sequencing and mass spectrometric analysis to determine the identity and function of the bacterial and host cells in the different regions of the GI tract and compared to similar analyses conducted on concomitantly collected stool samples.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18, living in Guediawaye district, Senegal

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur de Dakar: lead
• Bill and Melinda Gates Foundation: collaborator
• Aga Khan University: collaborator
• University of Zambia: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Centre de santé de Wakhinane

Guédiawaye, Dakar, Senegal

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yakhya Dieye, PhD

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Billo TALL, MD

CONTACT

+221 77 535 81 35; billo.tall@pasteur.sn

Yakhya Dieye, PhD

CONTACT

yakhya.dieye@pasteur.sn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomisation will be carried out using sealed envelopes, using a randomisation code prepared by the trial statistician, which will be stratified by study centre. Each woman who gives consent will be given a trial identification (TID) number which will match the number on the randomisation envelopes. The trial will be blinded with an identical placebo (by Next Gen Pharma India Pvt. India). Samples will be run and analysed using TID only, with all data cleaning and re-assays carried out blinded. The trial statistician will unblind lab data once databases are finalised.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 15, 2022
• Study Start: June 6, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 24 months of study completion.
• Access Criteria: Data access requests will be reviewed by the Trial Management Group. Requestors will be required to sign a Data Access Agreement.

Locations

SE (1)