~0 spots leftby Apr 2025

Microbiome Analysis and Education for Gut Health

Recruiting in Palo Alto (17 mi)
Overseen byKimberley Sukhum, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Seeding, Inc DBA Tiny Health
No Placebo Group

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.

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

My baby was born through a C-section.
My baby is between 0 to 3 months old.

Exclusion Criteria

Infants who have been given probiotic supplements in their life at recruitment
Infants who are not residents of the United States with US postal service
My baby was born before 36 weeks of pregnancy.
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Treatment Details

Interventions

  • Tailored Recommendations (Probiotics)
Trial OverviewThe study tests if personalized recommendations based on microbiome analysis, along with educational support, can positively impact an infant's gut health compared to just receiving this information after the study ends.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment3 Interventions
Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.
Group II: ControlActive Control1 Intervention
Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Seeding INCFredericksburg, TX
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Who Is Running the Clinical Trial?

Seeding, Inc DBA Tiny HealthLead Sponsor

References