Maternal & Offspring Microbiome Study
MOMS
Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedStudy Start
First participant enrolled
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 9, 2029
October 6, 2025
September 1, 2025
7.7 years
October 27, 2021
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month postpartum
Secondary Outcomes (13)
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 the maternal inflammatory marker profile
Baseline and 36 weeks of pregnancy
Characterize the infant inflammatory marker profile
6 months postpartum
Characterize the infant allergy marker profile
6 months postpartum
Infant Growth
18 months postpartum
- +8 more secondary outcomes
Study Arms (4)
Fiber
EXPERIMENTALParticipants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Fermented Foods
EXPERIMENTALParticipants will be asked to consume 6 servings of fermented foods per day.
Fiber + Fermented Foods
EXPERIMENTALParticipants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
Comparator
NO INTERVENTIONParticipants will receive usual care for pregnancy and postpartum.
Interventions
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- 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.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 39900290DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Garnder, PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehnborg Farquhar Professor of Medicine
Study Record Dates
First Submitted
October 27, 2021
First Posted
November 17, 2021
Study Start
January 12, 2022
Primary Completion (Estimated)
September 9, 2029
Study Completion (Estimated)
September 9, 2029
Last Updated
October 6, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share