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Probiotics

Probiotics for In Utero Drug Exposure (PROBIO Trial)

Phase 2
Waitlist Available
Led By Jean-Charles Pasquier, MD
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 37 weeks of gestation
Awards & highlights

PROBIO Trial Summary

This trial will test whether probiotics can be transmitted from mother to child in utero. Women who are low risk and pregnant will take either probiotics or a placebo between 34 weeks of pregnancy and 10 days post-partum.

PROBIO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
in-utero transmission of probiotic
Secondary outcome measures
postnatal transmission of probiotic to the neonate
Colostrum
Gastrointestinal tract structure
+2 more

PROBIO Trial Design

2Treatment groups
Active Control
Group I: postnatal probioticActive Control2 Interventions
will take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery
Group II: prenatal probioticActive Control2 Interventions
will take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
58 Previous Clinical Trials
31,113 Total Patients Enrolled
Lallemand Health SolutionsIndustry Sponsor
39 Previous Clinical Trials
3,667 Total Patients Enrolled
Jean-Charles Pasquier, MDPrincipal InvestigatorCIUSSS-Estrie-CHUS hospital

Media Library

Probiotics (Probiotics) Clinical Trial Eligibility Overview. Trial Name: NCT04050189 — Phase 2
In Utero Drug Exposure Research Study Groups: postnatal probiotic, prenatal probiotic
In Utero Drug Exposure Clinical Trial 2023: Probiotics Highlights & Side Effects. Trial Name: NCT04050189 — Phase 2
Probiotics (Probiotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050189 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a risk in taking probiotic supplements during pregnancy?

"While there is some evidence to support the safety of postnatal probiotic, it does not have a Phase 3 rating because efficacy has not been proven."

Answered by AI

Are researchers seeking more participants for this experiment?

"Yes, this trial is presently looking for patients to enroll. The clinical trial was initially posted on 4/27/2022 and was last updated on 5/4/2022 according to the information available on clinicaltrials.gov"

Answered by AI

Could I be a test subject for this experiment?

"The aim of this trial is to enroll 52 expectant mothers who have had in utero drug exposure. Additionally, these participants must be between 18-42 years old and meet the following criteria: having a low risk pregnancy, being pregnant with one child, intending to breastfeed postpartum, and being randomized between 32 0/7 - 33 6/7 weeks gestation."

Answered by AI

Is the age limit for this trial 75 years or younger?

"The age restriction for this clinical trial are patients that must be over 18 but under 42 years old."

Answered by AI

How many research participants are being enrolled in this clinical trial?

"Correct, the clinical trial is currently recruiting patients. According to information on clinicaltrials.gov, the first posting was on 4/27/2022 and there have been edits as recently as 5/4/2022. They are looking for 52 individuals total at 1 location."

Answered by AI
~18 spots leftby Mar 2025