Validation of the In-utero Transmission of Probiotics

NCT04050189 | Completed Phase 2

• 1 other identifier: 2020-3242
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

probiotic; in-utero transmission; pilot study

Outcome Measures

Primary Outcomes (1)

• in-utero transmission of probiotic

  presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium

  at birth

Secondary Outcomes (5)

• transmission of probiotic to colostrum

  at birth

• transmission of probiotic to maternal milk

  10 days postpartum

• transmission of probiotic to maternal vaginal tract

  37 weeks of gestation

• transmission of probiotic to maternal gut

  37 weeks of gestation

• postnatal transmission of probiotic to the neonate

  10 days postpartum

Study Arms (2)

prenatal probiotic

ACTIVE COMPARATOR

will take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery

Biological: Natural products: Probiotics; Other: Placebo

postnatal probiotic

ACTIVE COMPARATOR

will take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery

Biological: Natural products: Probiotics; Other: Placebo

Interventions

Natural products: Probiotics BIOLOGICAL

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

postnatal probiotic; prenatal probiotic

Placebo OTHER

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

postnatal probiotic; prenatal probiotic

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a single pregnancy
• Women with a low risk pregnancy
• Women wishing to breastfeed at birth
• Women randomized between 32 0/7 - 33 6/7 weeks of gestation

You may not qualify if:

• History of obstetric complications (prematurity \<37 weeks, preeclampsia , gestational diabetes treated with insulin)
• Obstetric or fetal complications known for current pregnancy such as threaten preterm labor (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or anomalies, corticosteroid therapy
• Risk factors for obstetric complications during current pregnancy such as gestational diabetes, type I / II diabetes and high blood pressure (systole ≥140 and diastole ≥90)
• Antibiotic use within 2 weeks before randomisation
• Intake of probiotics or foods enriched with active cultures (fermented milk, kefir, kombucha ...) within 2 weeks before randomisation
• Women positive for Group B Streptococcus during previous pregnancies
• Weakened immune system (AIDS, lymphoma, chemoradiotherapy or corticotherapy, immunosuppressive pathology)
• Allergy or intolerance to lactose, soy or yeast.
• Women under Coumadin
• Women who plan to give birth outside the participating center
• Women who do not plan to breastfeed or extract their milk in the first 10 days after delivery.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

CIUSSS de L'Estrie-CHUS Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

• Jean-Charles Pasquier, MD

  CIUSSS-Estrie-CHUS hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arms randomized crossover pilot study

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: April 27, 2022
• Primary Completion: August 28, 2023
• Study Completion: November 28, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)