Validation of the In-utero Transmission of Probiotics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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In Utero Drug Exposure

Intervention / Treatment
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* Biological: Natural products: Probiotics
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 2-arms randomized crossover pilot study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prenatal probiotic<br>will take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery | Biological: Natural products: Probiotics<br>* Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum<br>Other: Placebo<br>* Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum<br>|
| Active Comparator: postnatal probiotic<br>will take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery | Biological: Natural products: Probiotics<br>* Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum<br>Other: Placebo<br>* Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-utero transmission of probiotic | presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium | at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transmission of probiotic to colostrum | presence(yes or no) of probiotic (specific bacterial strains) in colostrum | at birth | 
| transmission of probiotic to maternal milk | presence (yes or no) of probiotic (specific bacterial strains) in breastmilk | 10 days postpartum | 
| transmission of probiotic to maternal vaginal tract | presence (yes or no) of probiotic (specific bacterial strains) in maternal vaginal swab | 37 weeks of gestation | 
| transmission of probiotic to maternal gut | presence (yes or no) of probiotic (specific bacterial strains) in maternal stools | 37 weeks of gestation | 
| postnatal transmission of probiotic to the neonate | presence (yes or no) of probiotic (specific bacterial strains) in neonate stools | 10 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, in-utero transmission, pilot study