Active — Not RecruitingNot Applicable

Maternal & Offspring Microbiome Study

United States135 participantsStarted 2022-01-12

Plain-language summary

The purpose of the study is to learn how different dietary interventions affect microbiota diversity in pregnant women and the transmission of microbiota to their infants during pregnancy, birth, and postpartum.

Who can participate

Age range

18 Years – 50 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: * \> 18 years of age * Singleton pregnancies * Recruit during the first trimester and up to 22 weeks of pregnancy. * Healthy subjects willing and able to provide blood, stool, vaginal swab, and breast milk samples. * Must be able to provide signed and dated informed consent. Exclusion Criteria: * Pre-pregnancy BMI greater than 40 * Blood pressure SBP: \> 160 mmHg -OR- DBP: \> 90 mmHg * Kidney disease * Liver disease * Anemia * Symptomatic gallstones * History of bariatric surgery * Acute disease at time of enrollment (i.e. flu or gastroenteritis). May delay sampling until subject recovers. * Chronic, clinically significant, unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history * History of active uncontrolled gastrointestinal disorders or diseases including: * Inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; * Irritable bowel syndrome (IBS) (moderate-severe); * Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated) * Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection. * Surgery of …

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

Difference in total number of species detected in stool as a measure of infant microbiota diversity.

Timeframe: 1 month postpartum

Trial details

NCT IDNCT05123612

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-09

View on ClinicalTrials.gov More Pregnancy Related trials