Microbiome Analysis and Education for Gut Health
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3 months delivered via Cesarean section. The main questions it aims to answer are: Will the intervention increase bacteria considered beneficial, decrease the C- section microbiome signatures, promote a reduction in opportunistic pathogens, and improved functional potential for HMO digestion and SCFA production Will the intervention decrease microbiome signatures associated with atopic march conditions.Researchers will compare participants in the intervention arm, who will receive microbiome reports, personalized action plans, and educational materials, to participants in the control arm, who will receive microbiome results and educational materials after the study's completion, to see if the intervention leads to improved gut health and reduced risk of health conditions.Participants will:* Provide two microbiome stool samples three months apart.* Receive detailed infant gut health reports via the Tiny Health app.* Receive personalized action plans tailored to their infant's gut health needs.* Engage in gut health coaching sessions with a microbiome expert.* Receive an educational email series on infant gut health.* Complete a series of surveys/questionnaires on health history, symptoms, and diet.This study seeks to demonstrate that targeted microbiome interventions can significantly improve early infant gut health, leading to potential long-term health benefits. These benefits may include reduced healthcare costs by lowering the incidence of related chronic conditions. By establishing a foundation for mitigating these conditions, the intervention could consequently result in fewer doctor visits, reduced need for medications, and a lower incidence of hospitalizations over the first 3-4 years of the infant's life.
Research Team
Kimberley Sukhum, PhD
Principal Investigator
Seeding INC
Eligibility Criteria
This trial is for infants aged 0-3 months who were delivered via Cesarean section. It aims to help parents improve their child's gut health and reduce future health risks through microbiome analysis and education.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants in the intervention arm receive microbiome reports, personalized action plans, and educational materials over six months
Control
Participants in the control arm receive microbiome results and educational materials after the study's completion
Follow-up
Participants are monitored for changes in microbiota composition and symptoms influenced by gut microbiome
Treatment Details
Interventions
- Tailored Recommendations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seeding, Inc DBA Tiny Health
Lead Sponsor