- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123612
Maternal & Offspring Microbiome Study (MOMS)
Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tayler Hennings, MPH
- Phone Number: 650-723-8114
- Email: taylerkl@stanford.edu
Study Contact Backup
- Name: Jennifer Robinson, PhD
- Phone Number: 650-736-8577
- Email: jlmorris@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fiber
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
|
Additional 20 grams of fiber/day.
|
Experimental: Fermented Foods
Participants will be asked to consume 6 servings of fermented foods per day.
|
6 servings of fermented foods/day
|
Experimental: 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.
|
Additional 20 grams of fiber/day.
6 servings of fermented foods/day
|
No Intervention: Comparator
Participants will receive usual care for pregnancy and postpartum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
Time Frame: 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.
|
1 month postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the total number of species detected in stool as a measure of maternal microbiota diversity.
Time Frame: 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.
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Baseline and 36 weeks of pregnancy
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Change in the maternal inflammatory marker profile
Time Frame: 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.
|
Baseline and 36 weeks of pregnancy
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Characterize the infant inflammatory marker profile
Time Frame: 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.
|
6 months postpartum
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Characterize the infant allergy marker profile
Time Frame: 6 months postpartum
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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.
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6 months postpartum
|
Infant Growth
Time Frame: 18 months postpartum
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Difference in weight-for-length growth chart percentiles between fiber, fermented, fiber + fermented, and comparator arms at 18 months postpartum.
|
18 months postpartum
|
Maternal Weight
Time Frame: 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.
|
36 weeks of pregnancy
|
Maternal systolic blood pressure
Time Frame: Baseline and 36 weeks of pregnancy
|
Change from baseline in systolic blood pressure at 36 weeks of pregnancy.
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Baseline and 36 weeks of pregnancy
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Maternal diastolic blood pressure
Time Frame: Baseline and 36 weeks of pregnancy
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Change from baseline in diastolic blood pressure at 36 weeks of pregnancy.
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Baseline and 36 weeks of pregnancy
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Maternal LDL-cholesterol
Time Frame: Baseline and 36 weeks of pregnancy
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Change from baseline in LDL cholesterol at 36 weeks of pregnancy.
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Baseline and 36 weeks of pregnancy
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Maternal HDL-cholesterol
Time Frame: Baseline and 36 weeks of pregnancy
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Change from baseline in HDL cholesterol at 36 weeks of pregnancy.
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Baseline and 36 weeks of pregnancy
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Maternal triglycerides
Time Frame: Baseline and 36 weeks of pregnancy
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Change from baseline in triglycerides at 36 weeks of pregnancy.
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Baseline and 36 weeks of pregnancy
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Maternal glucose
Time Frame: Baseline and 36 weeks of pregnancy
|
Change from baseline in glucose at 36 weeks of pregnancy.
|
Baseline and 36 weeks of pregnancy
|
Maternal fasting insulin
Time Frame: Baseline and 36 weeks of pregnancy
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Change from baseline in fasting insulin at 36 weeks of pregnancy.
|
Baseline and 36 weeks of pregnancy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher D Garnder, PhD, Stanford University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61806
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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