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Pregnancy RelatedMOMSNCT05123612

Maternal & Offspring Microbiome Study

A study testing Fiber and Fermented Foods in people with Pregnancy Related and Microbiome, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Microbiome, Immune Function
What is being tested?
Fiber and Fermented Foods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteUnited States
Study dates
12 Jan 2022to 9 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • > 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.

Who cannot join

  • Pre-pregnancy BMI greater than 40
  • Blood pressure SBP: > 160 mmHg -OR- DBP: > 90 mmHg
  • Kidney disease
  • Liver disease
  • Anemia
  • Symptomatic gallstones
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study

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.

Read the 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.

Being tested
Fiber, Fermented Foods
Keywords
Pregnancy, Microbiome, Immune function, Inflammation
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FiberBehavioural

    Additional 20 grams of fiber/day.

  • Fermented FoodsBehavioural

    6 servings of fermented foods/day

Study groups in NCT05123612
Study groupRoleWhat they receive
FiberExperimentalParticipants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Receives: Behavioral: Fiber
Fermented FoodsExperimentalParticipants will be asked to consume 6 servings of fermented foods per day.
Receives: Behavioral: Fermented Foods
Fiber + Fermented FoodsExperimentalParticipants will be asked to increase their usual dietary fiber intake by 20 grams/day and to consume 6 servings of fermented foods per day.
Receives: Behavioral: Fiber; Behavioral: Fermented Foods
ComparatorNo interventionParticipants will receive usual care for pregnancy and postpartum.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month postpartum

Secondary outcomes (13)

  1. 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.

    Measured: Baseline and 36 weeks of pregnancy

  2. 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.

    Measured: Baseline and 36 weeks of pregnancy

  3. 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.

    Measured: 6 months postpartum

  4. 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.

    Measured: 6 months postpartum

  5. Infant Growth

    Difference in weight-for-length growth chart percentiles between fiber, fermented, fiber + fermented, and comparator arms at 18 months postpartum.

    Measured: 18 months postpartum

  6. Maternal Weight

    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.

    Measured: 36 weeks of pregnancy

  7. Maternal systolic blood pressure

    Change from baseline in systolic blood pressure at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  8. Maternal diastolic blood pressure

    Change from baseline in diastolic blood pressure at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  9. Maternal LDL-cholesterol

    Change from baseline in LDL cholesterol at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  10. Maternal HDL-cholesterol

    Change from baseline in HDL cholesterol at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  11. Maternal triglycerides

    Change from baseline in triglycerides at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  12. Maternal glucose

    Change from baseline in glucose at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

  13. Maternal fasting insulin

    Change from baseline in fasting insulin at 36 weeks of pregnancy.

    Measured: Baseline and 36 weeks of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start12 Jan 2022
  3. Primary completion9 Sep 2029 (estimated)
  4. Study completion9 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123612
Sponsor's protocol ID
61806
Acronym
MOMS
Status last verified
Feb 2026
First submitted
27 Oct 2021
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39900290

Questions about this trial

What is this clinical trial studying?

A study testing Fiber and Fermented Foods in people with Pregnancy Related and Microbiome, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in total number of species detected in stool as a measure of infant microbiota diversity. (time frame: 1 month postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05123612, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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