Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2022-04-27
2023-11-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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prenatal probiotic
will take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery
Natural products: Probiotics
Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Placebo
Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
postnatal probiotic
will take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery
Natural products: Probiotics
Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Placebo
Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Interventions
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Natural products: Probiotics
Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Placebo
Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
42 Years
FEMALE
Yes
Sponsors
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Lallemand Health Solutions
INDUSTRY
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Responsible Party
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Principal Investigators
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Jean-Charles Pasquier, MD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS-Estrie-CHUS hospital
Locations
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CIUSSS de L'Estrie-CHUS Hospital
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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2020-3242
Identifier Type: -
Identifier Source: org_study_id