Maternal & Offspring Microbiome Study

N/AActive Not RecruitingNCT05123612

Stanford University135 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

135

Conditions

Interventions

FiberBEHAVIORAL

Additional 20 grams of fiber/day.

Fermented FoodsBEHAVIORAL

6 servings of fermented foods/day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 1 month postpartum

Secondary Outcomes

Change in the total number of species detected in stool as a measure of maternal microbiota diversity.

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.

Time frame: Baseline and 36 weeks of pregnancy

Change in the maternal inflammatory marker profile

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.

Time frame: Baseline and 36 weeks of pregnancy

Characterize the infant inflammatory marker profile

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.

Time frame: 6 months postpartum

Characterize the infant allergy marker profile

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.

Time frame: 6 months postpartum

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.