NCT07333482

Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants

Recruiting now NA Last updated 20 February 2026

What this trial tests

NA trial testing Tailored Recommendations in Microbiota in 250 participants. Currently enrolling.

Timeline

31 January 2026

Primary endpoint
1 June 2028

1 September 2028

Quick facts

Lead sponsor	Seeding Inc
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	250
Start date	31 January 2026
Primary completion	1 June 2028
Estimated completion	1 September 2028
Sites	1 location across United States

Drugs / interventions tested

• Tailored Recommendations
• Consult Call
• Educational Email Series

Conditions studied

• Microbiota — all drugs for Microbiota →
• Gut Microbiome — all drugs for Gut Microbiome →
• Eczema — all drugs for Eczema →
• Microbiome — all drugs for Microbiome →

Sponsor

Seeding Inc

Who can join

Adults 0 Months to 3 Months, any sex, with Microbiota or Gut Microbiome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Microbiota Composition
  Time frame: 24 months
  Changes in gut microbiota composition, including relative abundance of beneficial bacterial taxa such as Bifidobacterium, assessed using shotgun metagenomic sequencing.
• C-Section-Associated Microbiome Signatures
  Time frame: 24 months
  Changes in the relative abundance of microbial taxa and signatures previously associated with Cesarean delivery, assessed longitudinally using shotgun metagenomic sequencing.
• Opportunistic and Potentially Pathogenic Microbial Abundance
  Time frame: 24 months
  Changes in the relative abundance of opportunistic and potentially pathogenic microbial taxa over time, assessed using shotgun metagenomic sequencing.
• Functional Microbiome Capacity
  Time frame: 24 months
  Changes in microbial functional gene pathways related to human milk oligosaccharide (HMO) digestion and short-chain fatty acid (SCFA) production, assessed using metagenomic functional profiling.
• Eczema Incidence / Atopic Symptoms
  Time frame: 24 months
  Incidence of eczema and other early atopic symptoms assessed via parent-reported surveys and standardized eczema assessment when symptoms are reported.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.