Prenatal Probiotic Intervention

NCT03240419 | Completed

• 1 other identifier: 203392
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obesity; Inflammation; Pregnancy; Programming

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Probiotics

EXPERIMENTAL

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.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

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

Also known as: live cultures

Probiotics

Placebo DIETARY_SUPPLEMENT

capsule manufactured to mimic probiotic capsules.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is on pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related 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.

  PMID: 20089774 BACKGROUND

• 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.

  PMID: 19646321 BACKGROUND

• 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.

  PMID: 20970896 BACKGROUND

Related Links

• Arkansas Children's Nutrition Center website

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Inflammation; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eva C Diaz Fuentes, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 7, 2017
• Study Start: August 23, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)