CompletedNot Applicable

Prenatal Probiotic Intervention

United States60 participantsStarted 2017-08-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in acceptance of probiotic supplementation throughout pregnancy in obese women.

Timeframe: 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.

Timeframe: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36

Trial details

NCT IDNCT03240419

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-26

View on ClinicalTrials.gov More Childhood Obesity trials