Prenatal Probiotic Intervention

Not Applicable

Completed

• Conditions: Childhood Obesity; Maternal Obesity During Childbirth; Inflammation; Insulin Resistance
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT03240419
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-08-23
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in acceptance of probiotic supplementation throughout pregnancy in obese women.	Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36	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.
Change in compliance with probiotic supplementation throughout pregnancy in obese women.	Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36	Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States