Clinical trial NCT03240419: Prenatal Probiotic Intervention
Official title: Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Maternal Obesity During Childbirth
Insulin Resistance
Inflammation
Keywords: Obesity
Inflammation
Pregnancy
Programming
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
timeFrame: Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
measure: Change in compliance with probiotic supplementation throughout pregnancy in obese women.
timeFrame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Eva C Diaz Fuentes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor M, Garaiova I, Plummer SF, Wang D, Morgan G. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr. 2010 Mar;140(3):483-8. doi: 10.3945/jn.109.117093. Epub 2010 Jan 20.
citation: Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9.
citation: Ilmonen J, Isolauri E, Poussa T, Laitinen K. Impact of dietary counselling and probiotic intervention on maternal anthropometric measurements during and after pregnancy: a randomized placebo-controlled trial. Clin Nutr. 2011 Apr;30(2):156-64. doi: 10.1016/j.clnu.2010.09.009.