Validation of the In-utero Transmission of Probiotics (NCT04050189) | Clinical Trial Compass
CompletedPhase 2
Validation of the In-utero Transmission of Probiotics
Canada52 participantsStarted 2022-04-27
Plain-language 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.
Who can participate
Age range18 Years – 42 Years
SexFEMALE
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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.
What they're measuring
1
in-utero transmission of probiotic
Timeframe: at birth
Trial details
NCT IDNCT04050189
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke