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Prenatal Probiotic Intervention

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ClinicalTrials.gov Identifier: NCT03240419
Recruitment Status : Unknown
Verified September 2017 by Arkansas Children's Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : August 7, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Maternal Obesity During Childbirth Insulin Resistance Inflammation Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is on pregnant women.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240419


Contacts
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Contact: Eva C Diaz Fuentes, MD 501-364-3056 ecdiazfuentes@uams.edu
Contact: Aline Andres, PhD 501-364-3301 AndresAline@uams.edu

Locations
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United States, Arkansas
Arkansas Children's Nutrition Center Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Eva C Diaz Fuentes, MD    501-364-3056    ecdiazfuentes@uams.edu   
Contact: Aline Andres, MD    501-364-3301    AndresAline@uams.edu   
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Eva C Diaz Fuentes, MD University of Arkansas

Publications:
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03240419     History of Changes
Other Study ID Numbers: 203392
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arkansas Children's Hospital Research Institute:
Obesity
Inflammation
Pregnancy
Programming
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Pediatric Obesity
Inflammation
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases