Metabolism, Breastmilk, and Microbiome (NCT03522597) | Clinical Trial Compass
CompletedNot Applicable
Metabolism, Breastmilk, and Microbiome
United States2,050 participantsStarted 2018-06-01
Plain-language summary
The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropometric and body composition changes in their infants during the first 6 months of life. It is hypothesized that 1) different maternal metabolic states will be associated with differences in breastmilk microbial communities and breastmilk biochemical features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3) breastmilk microbial and metabolic features will be associated with infant growth outcomes.
Who can participate
Sex
ALL
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
. Pregnant women
. age 21-45 at time of delivery
. report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity \>1, that they successfully breastfed after a previous pregnancy for at least 3 months
. singleton pregnancy
. known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test \>200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion criteria
. alcohol consumption \>1 drink per week during pregnancy/lactation
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.