Eczema Clinical Trial - Infant Restore: Efficacy of Microbiome Analysis &

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06424691
Study type	Interventional
Source	Seeding, Inc DBA Tiny Health
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 4, 2023
Completion date	April 14, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Infant Restore: Efficacy of Microbiome Analysis and Education

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms