NCT07333482Recruiting
Flourish: Exploring the Early Infant Gut Microbiome
Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 31 Jan 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Seeding Inc
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07333482
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 31 Jan 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 0 months to 3 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seeding Labs INC Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.