Maternal & Offspring Microbiome Study

Not Applicable

Active, not recruiting

• Conditions: Microbiome; Pregnancy Related; Inflammation; Immune Function
• Interventions: Behavioral: Fiber; Behavioral: Fermented Foods

• Registration Number: NCT05123612
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-17
• Study Start: 2022-01-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-09-09
• Study Completion: 2025-09-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 135

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.

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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 the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
• Confirmed or suspected autoimmune disease

Medications:

• Weight loss medications
• Regular high dose aspirin
• Regular use of prescription opiate pain medication

If taken in the past 2 months:

• Systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular or oral)
• Corticosteroids (intravenous, intramuscular, oral, nasal or inhaled)
• Cytokines
• Methotrexate or immunosuppressive cytotoxic agents

Diet & Lifestyle:

• Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
• Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products

Maternal chronic medical conditions:

• Pre-gestational diabetes (T1 or T2)
• History of gestational diabetes
• On medication that is an immune modulators or chronic steroid use
• Hyperemesis gravidarum

Pregnancy history:

• Preterm birth
• Recurrent pregnancy loss

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiber	Fiber	Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Fermented Foods	Fermented Foods	Participants will be asked to consume 6 servings of fermented foods per day.
Fiber + Fermented Foods	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.
Fiber + Fermented Foods	Fiber	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.

Primary Outcome Measures

Name	Time	Method
Difference in total number of species detected in stool as a measure of infant microbiota diversity.	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 Outcome Measures

Name	Time	Method
Characterize the infant allergy marker profile	6 months postpartum	Difference in amount of allergy markers (skin prick testing) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Characterize the infant inflammatory marker profile	6 months postpartum	Difference in amount of inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in heel stick blood between fiber, fermented, fiber + fermented, and comparator arms at 6 months postpartum.
Change in the maternal inflammatory marker profile	Baseline and 36 weeks of pregnancy	Change in the differences in inflammatory markers (β-NGF, LIF-R, IL-12B, IL10, CASP-8, LAP TGF-β-1, CD6, CD5, MCP-2, IL6, CCL20, IL18, VEGFA, MMP-10, MCP-4, CCL4, CXCL10, CCL19, FGF-21) detected in blood samples from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Maternal Weight	36 weeks of pregnancy	Differences in the number of participants who gained weight within the pregnancy weight gain recommendations between fiber, fermented, fiber + fermented, and comparator arms measured at 36 weeks.
Maternal glucose	Baseline and 36 weeks of pregnancy	Change from baseline in glucose at 36 weeks of pregnancy.
Maternal fasting insulin	Baseline and 36 weeks of pregnancy	Change from baseline in fasting insulin at 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	Change in differences in total number of species (ASVs- Amplicon Sequence Variants) detected in stool from baseline to 36 weeks of pregnancy between fiber, fermented, fiber + fermented, and comparator arms.
Infant Growth	18 months postpartum	Difference in weight-for-length growth chart percentiles between fiber, fermented, fiber + fermented, and comparator arms at 18 months postpartum.
Maternal triglycerides	Baseline and 36 weeks of pregnancy	Change from baseline in triglycerides at 36 weeks of pregnancy.
Maternal LDL-cholesterol	Baseline and 36 weeks of pregnancy	Change from baseline in LDL cholesterol at 36 weeks of pregnancy.
Maternal HDL-cholesterol	Baseline and 36 weeks of pregnancy	Change from baseline in HDL cholesterol at 36 weeks of pregnancy.
Maternal systolic blood pressure	Baseline and 36 weeks of pregnancy	Change from baseline in systolic blood pressure at 36 weeks of pregnancy.
Maternal diastolic blood pressure	Baseline and 36 weeks of pregnancy	Change from baseline in diastolic blood pressure at 36 weeks of pregnancy.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States