Diet Intervention for Pregnancy Microbiome

(MOMS Trial)

Overseen By Jennifer Robinson, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Weight loss, Opiates, Aspirin, others

Disqualifiers: Obesity, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets impact the variety of gut bacteria in pregnant women and how these changes might affect their babies. Participants will either eat more fermented foods, increase fiber intake, or do both, while some will maintain their usual diet. The goal is to determine how these dietary changes can influence health during pregnancy and after birth. Women in the early stages of a single pregnancy who are generally healthy are the best fit for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance maternal and infant health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking weight loss medications, regular high dose aspirin, or regular prescription opiate pain medication, you may not be eligible to participate. Additionally, if you have taken certain medications like antibiotics or corticosteroids in the past two months, you may also be excluded.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that fermented foods like yogurt and miso soup are well-tolerated by pregnant women and may even lower the risk of early birth. However, some research suggests improper fermentation can affect gut bacteria. Overall, fermented foods are generally considered safe.

Regarding fiber, studies have shown that a high-fiber diet is safe and can increase the variety of beneficial gut bacteria, which is important for both mothers and babies. There are no major safety concerns with consuming more fiber during pregnancy.

Combining fiber and fermented foods appears promising, but limited data exist on their combined safety. However, both are usually safe individually and are thought to improve gut health together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they harness the natural power of diet to potentially improve pregnancy health, focusing specifically on the microbiome. Unlike standard prenatal care, which often involves supplements and medications, these treatments use fermented foods and fiber to naturally influence gut health. Fermented foods introduce beneficial probiotics, while increased fiber intake supports digestive health and regularity. By combining these dietary elements, researchers hope to uncover a simple, food-based strategy that could enhance maternal and fetal health during pregnancy.

What evidence suggests that this trial's dietary interventions could be effective for microbiota diversity in pregnancy?

This trial will compare different dietary interventions during pregnancy. Research has shown that eating fermented foods, which participants in one arm of this trial will consume, can increase the variety of beneficial bacteria in the body and strengthen the immune system. These foods help develop a healthy gut in both mothers and their babies. Another arm of this trial will focus on increasing dietary fiber intake, which links to positive changes in gut bacteria and better overall health during pregnancy. Observational studies suggest that combining fermented foods and fiber, as tested in another arm of this trial, might enhance these benefits, supporting the health of both mother and baby. These dietary changes might help reduce risks like pre-term birth and improve long-term health outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher D Garnder, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Recruit during the first trimester and up to 22 weeks of pregnancy

Singleton pregnancies

Healthy subjects willing and able to provide blood, stool, vaginal swab, and breast milk samples

Exclusion Criteria

I do not have ongoing major health issues with my lungs, heart, stomach, liver, or kidneys that require frequent medical attention.

I do not have active, uncontrolled GI disorders or a history of major GI surgery.

I have a liver condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline and Randomization

Baseline visit and sample collection followed by randomization to dietary intervention groups

1 week

1 visit (in-person)

Treatment

Participants follow assigned dietary interventions and provide periodic samples

36 weeks

Multiple visits (in-person and virtual)

Postpartum Follow-up

Participants and infants are monitored for microbiome diversity and health markers

6 months postpartum

Multiple visits (in-person and virtual)

Extension

Optional continuation to assess long-term dietary impacts on microbiome

3.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Fermented Foods
• Fiber

Trial Overview 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.

How Is the Trial Designed?

Group I: Fiber + Fermented Foods Experimental Treatment 2 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: Fiber Experimental Treatment 1 Intervention

Participants will be asked to increase their usual dietary fiber intake by 20 grams/day.

Group III: Fermented Foods Experimental Treatment 1 Intervention

Participants will be asked to consume 6 servings of fermented foods per day.

Group IV: Comparator Active Control 1 Intervention

Participants will receive usual care for pregnancy and postpartum.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A 17-week study with 36 healthy adults showed that a high-fiber diet increased specific enzymes in the gut microbiome but did not change overall immune response, indicating a complex relationship between diet and immune function.

In contrast, a diet rich in fermented foods improved microbiome diversity and reduced inflammation, suggesting that such foods could help combat the negative effects of low diversity and high inflammation common in modern diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut-microbiota-targeted diets modulate human immune status. Wastyk, HC., Fragiadakis, GK., Perelman, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176608/

The role of fermented foods in maternal health during ... Fermented foods such as miso soup, yogurt, cheese and fermented soybeans have been shown to reduce the risk of pre-term birth (25). In this ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12108452/

Effects of fermented and fiber-rich foods on maternal ... Observational studies suggest that increased intake of fermented foods during pregnancy may desirably modulate the gut microbiota; however, the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596323003792

The effects of fermented food consumption in pregnancy on ... The study results have already confirmed that fermented food consumption during pregnancy has a positive effect on microbiota development and facilitates ...

4. med.stanford.edu med.stanford.edu/news/all-news/2021/07/fermented-food-diet-increases-microbiome-diversity-lowers-inflammation.html

Fermented-food diet increases microbiome diversity ... Stanford researchers discover that a 10-week diet high in fermented foods boosts microbiome diversity and improves immune responses.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442500028X

Effects of fermented and fiber-rich foods on maternal & ... Here, we describe the study design and methods for our randomized controlled trial, the fermented and fiber-rich foods on maternal and offspring microbiome ...

6. environhealthprevmed.biomedcentral.com environhealthprevmed.biomedcentral.com/articles/10.1186/s12199-019-0782-z

Fermented foods and preterm birth risk from a prospective ... PTB low-risk women with a high consumption of miso soup, yogurt, and fermented soybeans before pregnancy have a reduced risk of early PTB.

7. mdpi.com mdpi.com/2304-8158/13/24/4024

The Safety of Probiotics Intended for Use in Pregnant and ... Overall, probiotic trials involving pregnant or lactating women have shown that these products are usually well-tolerated and safe although adverse effects may ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ntls.70002

A Review: Correlation Between Fermented Food and ... The fermentative food can also cause harmfulness and disturb the microbiome residing within the human body if the fermentation is carried out ...