Maternal & Offspring Microbiome Study (NCT05123612) | Clinical Trial Compass
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 range18 Years – 50 Years
SexFEMALE
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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 …
What they're measuring
1
Difference in total number of species detected in stool as a measure of infant microbiota diversity.