Actively Recruiting

Phase Not Applicable
Age: 0Months - 3Months
All Genders
Healthy Volunteers
NCT07333482

Flourish: Exploring the Early Infant Gut Microbiome

Led by Seeding Inc · Updated on 2026-02-24

250

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

Sponsors

S

Seeding Inc

Lead Sponsor

L

Laboratory Corporation of America

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Flourish: Exploring the Early Infant Gut Microbiome

Who Can Participate

Age: 0Months - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants aged 0 to 3 months at enrollment
  • Delivered via Cesarean section (scheduled or emergent)
  • Born at or after 36 weeks gestation
  • Infants and caregivers must live in the United States with a US mailing address
Not Eligible

You will not qualify if you...

  • Infants who have received probiotic supplements or formula with probiotics prior to recruitment
  • Twins or multiple births
  • Infants with gastrointestinal conditions such as Hirschsprung disease, eosinophilic gastrointestinal disorders, necrotizing enterocolitis, or short bowel syndrome
  • Infants with immune or autoimmune conditions including Severe Combined Immunodeficiency or HIV, excluding eczema and rashes
  • Infants with congenital conditions like cleft lip/palate, congenital heart disease, cerebral palsy, fragile X syndrome, Down syndrome, spina bifida, cystic fibrosis, phenylketonuria, congenital hypothyroidism, or galactosaemia
  • Infants with blood disorders such as sickle cell disease, thalassemia, or hemophilia
  • Infants or immediate family members who have previously received results from at-home microbiome stool tests (excluding standard clinical diagnostic tests)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Seeding Labs INC

Austin, Texas, United States, 78749

Actively Recruiting

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Research Team

K

Kimberley Sukhum, PhD

CONTACT

C

Claudia Nakama, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Flourish: Exploring the Early Infant Gut Microbiome | DecenTrialz