Prenatal Probiotic Intervention

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Inflammation; Insulin Resistance; Childhood Obesity; Maternal Obesity During Childbirth

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03240419

203392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo