Flourish: Early infant gut microbiome program for babies born by C-section
Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants
This project tests whether microbiome analysis, education, and personalized recommendations can improve gut bacteria and reduce early immune-related markers in babies born by C-section aged 0–3 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 0 Months to 3 Months |
| Sex | All |
| Sponsor | Seeding Inc Industry-sponsored |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT07333482 on ClinicalTrials.gov |
What this trial studies
Flourish enrolls infants aged 0–3 months delivered by Cesarean and randomizes them to a full intervention (microbiome reports, coaching, tailored recommendations, and educational materials), a limited intervention (simplified reports and basic recommendations), or a control that receives results after completion. Researchers collect stool samples and analyze microbiome composition and function to measure beneficial bacteria, C-section-associated signatures, opportunistic pathogens, HMO digestion potential, and short-chain fatty acid production. The interventions include personalized recommendations, consult calls, and an educational email series, with exclusion of infants given probiotic supplements, multiples, preterm under 36 weeks, or with certain gastrointestinal or immune conditions. Primary outcomes include shifts in microbiome composition and the prevalence of early atopic symptoms over the study period.
Who should consider this trial
Good fit: Ideal candidates are singleton infants aged 0–3 months born by Cesarean at ≥36 weeks gestation who live in the United States and have not received probiotic supplements.
Not a fit: Infants with prior probiotic exposure, multiple births, preterm delivery under 36 weeks, or existing gastrointestinal or immune disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could help shift infants' gut microbiomes toward healthier profiles and reduce early signs of allergy or eczema.
How similar studies have performed: Previous research has shown some ability to modify early gut colonization and associations with allergy risk, but personalized microbiome coaching and tailored recommendations like these are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment. * Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent. * Infants must have been at least 36 weeks gestation at time of delivery. * Infants and their caregivers must reside in the United States with a US mailing address. Exclusion Criteria: * Infants can not have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition. * Twin and multiple birth infants are not accepted in this study. * Infants cannot have the following existing health conditions: * Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS) * Immune or auto-immune conditions: Severe Combined Immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes * Congenital conditions: cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia) * Blood disorders (sickle cell disease, thalassemia, hemophilia) * Infant or any immediate family member has previously received results from an at-home microbiome stool test (excluding standard clinical diagnostic testing such as stool culture or pathogen testing)
Where this trial is running
Austin, Texas
- Seeding Labs INC — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Qian Yuan, MD — Massachusetts General Hospital
- Study coordinator: Kimberley Sukhum, PhD
- Email: hello@seedinglabs.co
- Phone: 512-827-9765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.