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Validation of the In-utero Transmission of Probiotics

NCT04050189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-05

No results posted yet for this study

Summary

This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5 bacterial strains) compared to placebo.

Conditions

  • In Utero Drug Exposure

Interventions

BIOLOGICAL

Natural products: Probiotics

Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum

OTHER

Placebo

Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    lead OTHER

Principal Investigators

  • Jean-Charles Pasquier, MD · CIUSSS-Estrie-CHUS hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2023-08-28
Completion
2023-11-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050189 on ClinicalTrials.gov