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Diet Intervention for Pregnancy Microbiome (MOMS Trial)

N/A
Waitlist Available
Led By Christopher D Garnder, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18 years of age or older
Be between 18 and 65 years old
Must not have
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
History of bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months postpartum
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how different diets affect the microbes in pregnant women and if these changes are passed to their infants.

Who is the study for?
This trial is for healthy pregnant women over 18, in their first trimester up to 22 weeks. Participants must be carrying a single baby and able to give samples of blood, stool, vaginal swab, and breast milk. They cannot join if they have severe obesity, high blood pressure, certain diseases (like autoimmune or liver disease), recent GI surgery (except gallbladder or appendix removal), or are immunocompromised.
What is being tested?
The study examines how diets rich in fermented foods or fiber influence the diversity of gut bacteria in mothers-to-be and the transfer of these microbes to their babies during pregnancy and after birth.
What are the potential side effects?
Since this trial involves dietary changes with fermented foods and fiber rather than medication, side effects may include digestive discomfort such as bloating or gas but will vary based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active, uncontrolled GI disorders or a history of major GI surgery.
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I have had weight loss surgery in the past.
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I have anemia.
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I have painful gallstones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
Secondary study objectives
Change in the maternal inflammatory marker profile
Change in the total number of species detected in stool as a measure of maternal microbiota diversity.
Characterize the infant allergy marker profile
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Fiber + Fermented FoodsExperimental Treatment2 Interventions
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 II: FiberExperimental Treatment1 Intervention
Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.
Group III: Fermented FoodsExperimental Treatment1 Intervention
Participants will be asked to consume 6 servings of fermented foods per day.
Group IV: ComparatorActive Control1 Intervention
Participants will receive usual care for pregnancy and postpartum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fermented Foods
2016
N/A
~40
Fiber
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,515,986 Total Patients Enrolled
Christopher D Garnder, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Fermented Foods Clinical Trial Eligibility Overview. Trial Name: NCT05123612 — N/A
Pregnancy Research Study Groups: Fermented Foods, Comparator, Fiber, Fiber + Fermented Foods
Fermented Foods 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123612 — N/A
Pregnancy Clinical Trial 2023: Fermented Foods Highlights & Side Effects. Trial Name: NCT05123612 — N/A
~25 spots leftby Sep 2025
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