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

135 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Fermented Foods, Fiber, Dietary Fiber for pregnancy microbiome?

Research suggests that high dietary fiber intake during pregnancy can positively influence the gut microbiome by promoting beneficial bacteria, which may help regulate glucose metabolism and reduce inflammation. Additionally, whole grains, which are high in fiber, may affect the vaginal microbiome, potentially benefiting maternal and neonatal health. ^{1 2 3 4 5}

Is it safe to consume whole grains and high-fiber foods during pregnancy?

Research suggests that consuming whole grains and high-fiber foods during pregnancy is generally safe. Studies have shown no adverse effects on maternal weight gain, birth weight, or glucose tolerance, and participants reported high satisfaction with dietary interventions. ^{1 3 6 7 8}

How does the treatment of fermented foods and fiber for pregnancy microbiome differ from other treatments?

This treatment is unique because it focuses on altering the gut microbiome through dietary changes, specifically by increasing the intake of fermented foods and fiber, which can enhance beneficial bacteria and reduce inflammation. Unlike other treatments that might use medications, this approach leverages natural dietary components to improve gut health and potentially influence immune function. ^{9 10 11 12 13}

Research Team

Christopher D Garnder, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

I am 18 years old or older.

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

Singleton pregnancies

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Low dietary fiber intake increases Collinsella abundance in the gut microbiota of overweight and obese pregnant women. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Maternal Gut Microbiome Biodiversity in Pregnancy. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal Vegetable and Fruit Consumption during Pregnancy and Its Effects on Infant Gut Microbiome. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal gut microbiota Bifidobacterium promotes placental morphogenesis, nutrient transport and fetal growth in mice. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Food Delivery Intervention during Pregnancy in a Rural US Population: The PEAPOD Pilot Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Targeting the perinatal diet to modulate the gut microbiota increases dietary variety and prebiotic and probiotic food intakes: results from a randomised controlled trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The association between the maternal diet and the maternal and infant gut microbiome: a systematic review. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Different fibers have different regional effects on luminal contents of rat colon. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Understanding the prebiotic potential of different dietary fibers using an in vitro continuous adult fermentation model (PolyFermS). [2019]

11. United States pubmed.ncbi.nlm.nih.gov

High-Fiber, Whole-Food Dietary Intervention Alters the Human Gut Microbiome but Not Fecal Short-Chain Fatty Acids. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Gut-microbiota-targeted diets modulate human immune status. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Fermentability of various fiber sources by human fecal bacteria in vitro. [2023]