CompletedNot Applicable

Pediatric Obesity and the Infant Microbiome (BEACH)

United States83 participantsStarted 2017-04-28

Plain-language summary

The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.

Who can participate

Age range

18 Years – 45 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: * Between the ages of 18 and 45 years of age. * Pre-pregnancy BMI is greater than 30 kg/m2 * Pre-pregnancy BMI is less than 25 kg/m2 * At risk for gestational diabetes * Pregnant and have Type 1 diabetes (T1D) * Pregnant and have Type 2 diabetes (T2D) * pregnant and within the 3rd trimester (34-36 weeks of gestation)-You plan to deliver in the Greater Gainesville area * Plan to deliver via vaginal or cesarean section * Plan to exclusively breastfeed your infant for at least 2 months * Child will receive their pediatric care through UFHealth Exclusion Criteria: * Smoking * Pre-eclampsia * History of pre-term delivery (\<35 weeks) * Only one breast capable of lactation and milk production inadequate * Age \<18 yrs, \>45 yrs * Any maternal antibiotics in the last 2 weeks during delivery * Any alcohol consumption * Drug use

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

Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)

Timeframe: 1 year

Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)

Timeframe: 1 year

Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS).

Timeframe: 1 year

Trial details

NCT IDNCT02843087

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-03

View on ClinicalTrials.gov More Pediatric Obesity trials

Who can participate

Age range

18 Years – 45 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.

What they're measuring

Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)

Timeframe: 1 year

Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)

Timeframe: 1 year

Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS).

Timeframe: 1 year