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

2020-3242

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.

2022-04-27

2023-08-28

2023-11-28

Completed

Early phase I

52

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '2-arms randomized crossover pilot study', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double-blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

2023-12-05