Status:
COMPLETED
Validation of the In-utero Transmission of Probiotics
Lead Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
In Utero Drug Exposure
Eligibility:
FEMALE
18-42 years
Phase:
PHASE2
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 f...
Detailed 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, o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04050189
Start Date
April 27 2022
End Date
November 28 2023
Last Update
December 5 2023
Active Locations (1)
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1
CIUSSS de L'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada, J1H 5N4