Flourish: Early infant gut microbiome program for babies born by C-section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.