Prenatal Probiotic Intervention

Study Overview
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Brief Summary
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This study will assess the feasibility of a randomized control trial in which the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation, as well offspring gene expression and body composition are examined.

Detailed Description
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Maternal obesity leads to increased insulin resistance and inflammation which have been shown to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic supplementation during pregnancy has been shown to improve insulin sensitivity in normal weight women. However, little is known on the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene expression and body composition. Long term nutritional supplementation, however, is associated with increased participant burden as well as lower compliance and retention rates. Thus, this study will assess the feasibility of a long term probiotic supplementation study in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy and study procedures will be assessed.

Official Title
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Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.

Conditions
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Childhood Obesity, Maternal Obesity During Childbirth, Insulin Resistance, Inflammation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 30 ≥ 18 years of age Singleton pregnancy Less than 12 weeks of gestation Less than 1 serving of yoghurt with live cultures or cultured milk per week Conceived without assisted fertility treatments Exclusion Criteria: • Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid disorders, heart disease or immune disorders) as determined by the PI to affect the outcomes of interest Immunosuppressed women Women taking medications during pregnancy known to affect fetal growth (i.e., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents) Women who are using recreational drugs, tobacco or alcohol during their pregnancy Milk intolerance or allergy Consuming probiotic supplements

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Each probiotic capsule contains 180 mg of a standardized white to light beige fine powder consisting of freeze-dried cultures. Specifically, Bifidobacterium BB-12® and Lactobacillus rhamnosus LGG® (50%:50%). This product has a minimum potency of 6.5 billion (6.5E+9) CFU (ColonyForming Units) per capsule. Other ingredients in the powder are: microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate. Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery. | Dietary Supplement: Probiotics<br>* Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.<br>* Other names: live cultures;|
| Placebo Comparator: Placebo<br>Participants in this group will take one capsule containing microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate (all ingredients listed in the probiotic capsules except the culture) . Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery. | Dietary Supplement: Placebo<br>* capsule manufactured to mimic probiotic capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acceptance of probiotic supplementation throughout pregnancy in obese women. | Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures. | Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 | 
| Change in compliance with probiotic supplementation throughout pregnancy in obese women. | Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count. | Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Inflammation, Pregnancy, Programming