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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
Seeding Labs INC
RECRUITING
Austin
Contact Information
Primary
Kimberley Sukhum, PhD
hello@seedinglabs.co
‪512-827-9765‬
Backup
Claudia Nakama, MPH
hello@seedinglabs.co
‪512-827-9765‬
Time Frame
Start Date: 2026-01-31
Estimated Completion Date: 2028-09
Participants
Target number of participants: 250
Treatments
Experimental: Full Intervention
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
Experimental: Limited Intervention Arm
Participants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner.
No_intervention: Control Arm
Participants in the control arm will provide the same level of microbiome and survey data as the intervention arms but will not see their results until after the completion of the study.
Related Therapeutic Areas
Sponsors
Leads: Seeding Inc
Collaborators: Laboratory Corporation of America

This content was sourced from clinicaltrials.gov