Flourish: Exploring the Early Infant Gut Microbiome

Last updated: February 20, 2026
Sponsor: Seeding Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rash

Allergy

Atopic Dermatitis

Treatment

Tailored Recommendations

Consult Call

Educational Email Series

Clinical Study ID

NCT07333482
FLOURISH_14952
  • Ages < 3
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.

Researchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.

Participants will:

  1. Provide six microbiome stool samples over a 24-month period.

  2. Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.

  3. Receive microbiome reports and guidance according to their assigned study arm.

  4. Complete surveys on infant health history, symptoms, diet, and environmental exposures.

  5. Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.

This study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants are qualified for this study if they are 0 to 3 months of age at time ofenrollment.

  • Infants must have been delivered via Cesarean delivery (C-section), either scheduledor 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 mailingaddress.

Exclusion

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 ormultivitamin 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 gastrointestinaldisorders (EGID) including eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS)

  • Immune or auto-immune conditions: Severe Combined Immunodeficiency (SCID), humanimmunodeficiency virus (HIV)), excluding eczema and rashes

  • Congenital conditions: cleft lip or cleft palate, congenital heart disease, cerebralpalsy, 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 anat-home microbiome stool test (excluding standard clinical diagnostic testing suchas stool culture or pathogen testing)

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: Tailored Recommendations
Phase:
Study Start date:
January 31, 2026
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Seeding Labs INC

    Austin 4671654, Texas 4736286 78749
    United States

    Active - Recruiting

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