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Prenatal Probiotic Intervention

Primary Purpose

Childhood Obesity, Maternal Obesity During Childbirth, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Arkansas Children's Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Inflammation, Pregnancy, Programming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Arkansas Children's Nutrition Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2017
Last Updated
January 3, 2022
Sponsor
Arkansas Children's Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03240419
Brief Title
Prenatal Probiotic Intervention
Official Title
Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Children's Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Maternal Obesity During Childbirth, Insulin Resistance, Inflammation
Keywords
Obesity, Inflammation, Pregnancy, Programming

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
live cultures
Intervention Description
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
capsule manufactured to mimic probiotic capsules.
Primary Outcome Measure Information:
Title
Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
Description
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.
Time Frame
Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
Title
Change in compliance with probiotic supplementation throughout pregnancy in obese women.
Description
Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.
Time Frame
Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is on pregnant women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva C Diaz Fuentes, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Nutrition Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers.
Citations:
PubMed Identifier
20089774
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.
Results Reference
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PubMed Identifier
19646321
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.
Results Reference
background
PubMed Identifier
20970896
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.
Results Reference
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Links:
URL
https://acnc.uams.edu/home/studies/
Description
Arkansas Children's Nutrition Center website

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Prenatal Probiotic Intervention

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