NCT03240419

Prenatal Probiotic Intervention

Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Childhood Obesity
• Maternal Obesity During Childbirth
• Insulin Resistance
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
DIETARY_SUPPLEMENT	Placebo	capsule manufactured to mimic probiotic capsules.

Timeline

• Start date: 2017-08-23
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2017-08-07
• Last updated: 2022-01-18

Locations

1 site across 1 country: United States