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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber | Experimental | Participants will be asked to increase their usual dietary fiber intake by 20 grams/day. |
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| Fermented Foods | Experimental | Participants will be asked to consume 6 servings of fermented foods per day. |
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| Fiber + Fermented Foods | Experimental | 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. |
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| Comparator | No Intervention | Participants will receive usual care for pregnancy and postpartum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber | Behavioral | Additional 20 grams of fiber/day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 36 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
Medications:
If taken in the past 2 months:
Diet & Lifestyle:
Maternal chronic medical conditions:
Pregnancy history:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Garnder, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39900290 | Derived | 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. |
| Label | URL |
|---|---|
| Study description | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D000074421 | Fermented Foods |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Fermented Foods |
| Behavioral |
6 servings of fermented foods/day |
|
| 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. | 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. | 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. | 6 months postpartum |
| Infant Growth | 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 | 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 | Change from baseline in systolic blood pressure at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal diastolic blood pressure | Change from baseline in diastolic blood pressure at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal LDL-cholesterol | Change from baseline in LDL cholesterol at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal HDL-cholesterol | Change from baseline in HDL cholesterol at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal triglycerides | Change from baseline in triglycerides at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal glucose | Change from baseline in glucose at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| Maternal fasting insulin | Change from baseline in fasting insulin at 36 weeks of pregnancy. | Baseline and 36 weeks of pregnancy |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |