Validation of the In-utero Transmission of Probiotics

In Utero Drug Exposure Clinical Trial

— PROBIO  

Official title:

Validation of the In-utero Transmission of Probiotics From the Mother to the Baby: A Randomized Crossover Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050189
• Other study ID #: 2020-3242
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2022
• Est. completion date: November 28, 2023

Study information

• Verified date: December 2023
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Rational: Studies have shown that probiotics given to babies can reduce perinatal complications. A change of practice should therefore be introduced in the management of premature newborns. However, one could assume that probiotic administration before birth could be as effective if not more. Indeed, one could hypothesise that when the newborn is exposed to probiotics earlier, the protective effect is potentially increased.

Objective: This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby.

Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study Products under study: Probiotics containing 5 bacterial strains (total of 12 million colony-forming unit / day) vs. Placebo.

Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical, socio-demographic data) and will be randomized (double-blind) in one of the 2 following groups:

Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery.

Group B: taking placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery.

Follow-up: All women will complete a logbook to monitor the study products intake and monitor side effects until the end of the study (10 days postpartum).

Samples: maternal stool samples, vaginal secretions, stool (and meconium) as well as breast milk (and colostrum) will be taken at different times of the study to confirm the presence of probiotics and transmission between the mother and the baby.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• In Utero Drug Exposure

Intervention

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

Locations

Country	Name	City	State
Canada	CIUSSS de L'Estrie-CHUS Hospital	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Lallemand Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-utero transmission of probiotic	presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium	at birth
Secondary	transmission of probiotic to colostrum	presence(yes or no) of probiotic (specific bacterial strains) in colostrum	at birth
Secondary	transmission of probiotic to maternal milk	presence (yes or no) of probiotic (specific bacterial strains) in breastmilk	10 days postpartum
Secondary	transmission of probiotic to maternal vaginal tract	presence (yes or no) of probiotic (specific bacterial strains) in maternal vaginal swab	37 weeks of gestation
Secondary	transmission of probiotic to maternal gut	presence (yes or no) of probiotic (specific bacterial strains) in maternal stools	37 weeks of gestation
Secondary	postnatal transmission of probiotic to the neonate	presence (yes or no) of probiotic (specific bacterial strains) in neonate stools	10 days postpartum