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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months postpartum
Awards & highlights

MOMS Trial 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.Check my eligibility
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.See study design
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.

MOMS Trial Eligibility Criteria

Inclusion Criteria

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

MOMS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in total number of species detected in stool as a measure of infant microbiota diversity.
Secondary outcome measures
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

MOMS 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
2,387 Previous Clinical Trials
17,333,915 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this medical study limited to adults, or are minors also able to take part?

"This trial seeks participants who are below the age of 50 and have surpassed 18 years old."

Answered by AI

Are participants being enrolled at this time for the research project?

"As per the information available on clinicaltrials.gov, this study is in search of participants at present. It was initially published on December 1st 2022 and underwent its most recent alteration on January 20th 2022."

Answered by AI

What criteria do potential participants need to meet in order to qualify for this clinical study?

"This medical trial seeks 264 individuals afflicted with inflammation, aged between 18 and 50. The specific requirements are that applicants must be over the age of consent, recruited during the first trimester or up to 22 weeks gestation."

Answered by AI

What is the aggregate amount of people participating in this clinical trial?

"Indeed, the information published on clinicaltrials.gov demonstrates that this research is presently looking for volunteers. This trial was initially advertised on December 1st 2022 and has been recently refreshed as of January 20th 2022; it requires 264 participants to be enrolled at one location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Maternal & Offspring Microbiome Study
Christopher Gardner 2022. "Maternal & Offspring Microbiome Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123612.
All > Microbiome
~42 spots leftby Apr 2025
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