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Completed

NCT Number: NCT03240419

Prenatal Probiotic Intervention

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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

Other names: live cultures

Placebo

Dietary Supplement

capsule manufactured to mimic probiotic capsules.

Primary outcomes

  1. Change in acceptance of probiotic supplementation throughout pregnancy in obese women.

    Time frame: 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.

  2. Change in compliance with probiotic supplementation throughout pregnancy in obese women.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2017
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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