Flourish: Exploring the Early Infant Gut Microbiome
This study, called Flourish, is looking at whether analyzing an infant's gut microbiome (the community of tiny living things in their intestines), providing education, and offering personalized recommendations can improve gut health in babies. It focuses on infants aged 0 to 3 months who were born by C-section. The goal is to see if these interventions can increase helpful bacteria, reduce bacteria linked to C-sections, decrease harmful bacteria, and improve how well the gut can digest certain sugars and produce beneficial substances. Researchers also want to know if these gut changes lead to fewer early signs of conditions like eczema. The study is currently recruiting about 250 infants.
- Study design
- This is an interventional study planning to enroll 250 participants. It explores the effects of tailored recommendations, consult calls, and an educational email series.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' microbiota composition, C-section-associated microbiome signatures, and opportunistic microbial abundance will be measured at 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Flourish: Exploring the Early Infant Gut Microbiome
At a glance
Conditions
NCT07333482
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Seeding Labs INC
Austin, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Qian Yuan, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Microbiota Composition24 months
Changes in gut microbiota composition, including relative abundance of beneficial bacterial taxa such as Bifidobacterium, assessed using shotgun metagenomic sequencing.
- C-Section-Associated Microbiome Signatures24 months
Changes in the relative abundance of microbial taxa and signatures previously associated with Cesarean delivery, assessed longitudinally using shotgun metagenomic sequencing.
- Opportunistic and Potentially Pathogenic Microbial Abundance24 months
Changes in the relative abundance of opportunistic and potentially pathogenic microbial taxa over time, assessed using shotgun metagenomic sequencing.
- Functional Microbiome Capacity24 months
Changes in microbial functional gene pathways related to human milk oligosaccharide (HMO) digestion and short-chain fatty acid (SCFA) production, assessed using metagenomic functional profiling.
- Eczema Incidence / Atopic Symptoms24 months
Incidence of eczema and other early atopic symptoms assessed via parent-reported surveys and standardized eczema assessment when symptoms are reported.