Prenatal Probiotic Intervention

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2019-03-26

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.

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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.

Conditions

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Childhood Obesity Maternal Obesity During Childbirth Insulin Resistance Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Probiotics

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.

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

capsule manufactured to mimic probiotic capsules.

Interventions

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Probiotics

Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.

Intervention Type DIETARY_SUPPLEMENT

Placebo

capsule manufactured to mimic probiotic capsules.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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live cultures

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes