Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
Overview
- Phase
- Not Applicable
- Intervention
- Fiber
- Conditions
- Inflammation
- Sponsor
- Stanford University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Difference in total number of species detected in stool as a measure of infant microbiota diversity.
- Status
- Active, not recruiting
- Last Updated
- 26 days ago
Overview
Brief 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.
Detailed Description
This research study aims to understand the relationship of dietary fiber, fermented foods, and the microbiome, specifically during pregnancy and postpartum. The investigators know that the composition of the microbiome can have an important effect on overall health, and a greater variety will confer more health benefits. Research suggests that maternal microbiota play an important role in the development of their offspring's microbiota during pregnancy, childbirth, and breastfeeding. The purpose of this study is to assess how diet impacts maternal microbiome during pregnancy and their infant's microbiome up to about two years postpartum. Potential pregnant participants will be recruited during their first trimester up to 22 weeks. After completion of the baseline visit and sample collection, they will be randomized to start a diet high in fiber, high in fermented foods, high in both fiber and fermented foods, or a usual care group. Participants will be asked to provide blood, stool, vaginal swab, and breast milk samples periodically throughout the study. Cord blood will be collected after childbirth, and infant blood from a heel stick will be collected twice. They will also be asked to fill out online questionnaires and perform dietary recalls with study diet assessors. After completing the study, participants will be invited to continue to participate in an extension of the study for approximately three and a half additional years. The purpose of this extension is to continue to assess how diet impacts the mother's microbiome postpartum and the child's microbiome up to about 5 years of age.
Investigators
Christopher Gardner
Rehnborg Farquhar Professor of Medicine
Stanford University
Eligibility Criteria
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
- •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;
Arms & Interventions
Fiber
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Intervention: Fiber
Fermented Foods
Participants will be asked to consume 6 servings of fermented foods per day.
Intervention: Fermented Foods
Fiber + Fermented Foods
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
Intervention: Fiber
Fiber + Fermented Foods
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
Intervention: Fermented Foods
Comparator
Participants will receive usual care for pregnancy and postpartum.
Outcomes
Primary Outcomes
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
Time Frame: 1 month postpartum
Difference in total number of species (ASVs - Amplicon Sequence Variants) detected in stool between the fiber, fermented, fiber + fermented and comparator arms at 1 month postpartum.
Secondary Outcomes
- Characterize the infant allergy marker profile(6 months postpartum)
- Characterize the infant inflammatory marker profile(6 months postpartum)
- Change in the maternal inflammatory marker profile(Baseline and 36 weeks of pregnancy)
- Maternal Weight(36 weeks of pregnancy)
- Maternal glucose(Baseline and 36 weeks of pregnancy)
- Maternal fasting insulin(Baseline and 36 weeks of pregnancy)
- Change in the total number of species detected in stool as a measure of maternal microbiota diversity.(Baseline and 36 weeks of pregnancy)
- Infant Growth(18 months postpartum)
- Maternal triglycerides(Baseline and 36 weeks of pregnancy)
- Maternal LDL-cholesterol(Baseline and 36 weeks of pregnancy)
- Maternal HDL-cholesterol(Baseline and 36 weeks of pregnancy)
- Maternal systolic blood pressure(Baseline and 36 weeks of pregnancy)
- Maternal diastolic blood pressure(Baseline and 36 weeks of pregnancy)