Maternal & Offspring Microbiome Study

NCT ID: NCT05123612

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2029-09-09

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.

Conditions

Pregnancy Related; Microbiome; Immune Function; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Fiber

Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.

Group Type: EXPERIMENTAL

Fiber

Intervention Type: BEHAVIORAL

Additional 20 grams of fiber/day.

Fermented Foods

Participants will be asked to consume 6 servings of fermented foods per day.

Group Type: EXPERIMENTAL

Fermented Foods

Intervention Type: BEHAVIORAL

6 servings of fermented foods/day

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.

Group Type: EXPERIMENTAL

Fiber

Intervention Type: BEHAVIORAL

Additional 20 grams of fiber/day.

Fermented Foods

Intervention Type: BEHAVIORAL

6 servings of fermented foods/day

Comparator

Participants will receive usual care for pregnancy and postpartum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fiber

Additional 20 grams of fiber/day.

Intervention Type: BEHAVIORAL

Fermented Foods

6 servings of fermented foods/day

Intervention Type: BEHAVIORAL

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Gardner

Rehnborg Farquhar Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher D Garnder, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Ward CP, Perelman D, Durand LR, Robinson JL, Cunanan KM, Sudakaran S, Sabetan R, Madrigal-Moeller MJ, Dant C, Sonnenburg ED, Sonnenburg JL, Gardner CD. Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) - Study design and methods. Contemp Clin Trials. 2025 Mar;150:107834. doi: 10.1016/j.cct.2025.107834. Epub 2025 Feb 1.

Reference Type: DERIVED

PMID: 39900290 (View on PubMed)

Related Links

https://med.stanford.edu/nutrition/research/current-studies/fefifo-moms.html

Study description

Other Identifiers

61806

Identifier Type: -

Identifier Source: org_study_id