Prenatal Probiotic Intervention

Inflammation Clinical Trial

Official title:

Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240419
• Other study ID #: 203392
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: March 26, 2019

Study information

• Verified date: January 2022
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Probiotics
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
• Placebo
capsule manufactured to mimic probiotic capsules.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

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

External Links

•   Arkansas Children's Nutrition Center website