Prenatal Probiotic Intervention

January 3, 2022 updated by: Arkansas Children's Hospital Research Institute

Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotics
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
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
Other Names:
  • live cultures
PLACEBO_COMPARATOR: Placebo
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
capsule manufactured to mimic probiotic capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
Time Frame: Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
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.
Time Frame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Eva C Diaz Fuentes, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 23, 2017

Primary Completion (ACTUAL)

March 26, 2019

Study Completion (ACTUAL)

March 26, 2019

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (ACTUAL)

August 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 203392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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