Prenatal Probiotic Intervention

Arkansas Children's Hospital Research Institute60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Childhood Obesity Maternal Obesity During Childbirth Insulin Resistance Inflammation

Interventions

ProbioticsDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

capsule manufactured to mimic probiotic capsules.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36

Data from ClinicalTrials.gov

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