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NCT06424691 · ClinicalTrials.gov registry record · NA
Infant Restore: Efficacy of Microbiome Analysis and Education
A NA study of Eczema and Gut Microbiome, sponsored by Seeding.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06424691 is a NA study of Eczema and Gut Microbiome that is active but no longer recruiting, run by Seeding. The registered enrollment target is 100 participants, below the 203-participant average among 29 other Eczema trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06424691, a NA study of Eczema and Gut Microbiome, is active but no longer recruiting, sponsored by Seeding.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Tailored Recommendations
- BEHAVIORAL Consult Call
- BEHAVIORAL Email Series
Study Locations (1)
Texas
- Seeding INC - Fredericksburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-05-04 |
| Est. Completion | 2025-04-14 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06424691
The ClinicalTrials.gov registry entry for NCT06424691 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 29 other Eczema trials with a reported enrollment target (51% lower). The listed sponsor is Seeding, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Eczema appearing as the primary indexed condition, and to 3 interventions - of which Tailored Recommendations is the first listed.
NCT06424691 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06424691 about?
NCT06424691 is a clinical study titled "Infant Restore: Efficacy of Microbiome Analysis and Education". 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 answ...
What is the current status of trial NCT06424691?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-05-04. Estimated completion is 2025-04-14.
What conditions does trial NCT06424691 study?
This clinical trial studies the following conditions: Eczema, Gut Microbiome, Microbiome, Microbiota.
What interventions are being tested in trial NCT06424691?
The interventions under investigation include: Tailored Recommendations (DIETARY_SUPPLEMENT), Consult Call (BEHAVIORAL), Email Series (BEHAVIORAL).
Who is sponsoring clinical trial NCT06424691?
This trial is sponsored by Seeding, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06424691 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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