Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

Study Overview
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Brief Summary
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The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.

Official Title
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Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant patients ≥ 18 years of age Singleton pregnancy Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days Exclusion Criteria: Pregnant patients <18 years of age Multiple gestations Gestational age less than or equal to 5 weeks and 6 days Gestational age greater than or equal to 14 weeks and 0 days Institutionalization for psychiatric disorder, mental retardation, or criminal activity Inability to provide informed consent Major medical complication of pregnancy, including but not limited to: Diabetes, Chronic hypertension, Severe obesity with body mass index greater than or equal to 40 kg/m2 Major surgical complications of pregnancy, including but not limited to: History of Bariatric surgery Major obstetrical complication of pregnancy, including but not limited to: History of spontaneous preterm birth Known maternal or fetal chromosomal abnormality Major fetal anomaly Intrauterine fetal demise Human immunodeficiency virus (HIV) or Hepatitis Chronic immunosuppressive medications or steroids Current use of probiotic supplementation Active urinary or vaginal infection Current use of antibiotics Current use of vaginal medication (e.g. vaginal progesterone) Cerclage in place

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br> | Dietary Supplement: Probiotic<br>* Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo, taken by mouth once daily for 4-6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaginal Microbiome, 16S rRNA |  | Baseline, and 4-6 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rectal Microbiome, 16S rRNA |  | Baseline, and 4-6 weeks after intervention | 
| Change in Urinary Microbiome, 16S rRNA |  | Baseline, and 4-6 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Probiotic