Maternal & Offspring Microbiome Study — MOMS  

Inflammation Clinical Trial

Official title: Effects of Fermented & Fiber-rich Foods on Maternal & Offspring Microbiome Study

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Immune Function
• Inflammation
• Microbiome
• Pregnancy Related

• NCT number: NCT05123612
• Study type: Interventional
• Source: Stanford University
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2022
• Completion date: September 9, 2025