Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424691
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Infant Restore Efficacy of Microbiome Analysis and Education
Sponsor:
Seeding Inc DBA Tiny Health
Organization:
Seeding Inc DBA Tiny Health
Study Overview
Official Title:
Infant Restore Investigating the Efficacy of a Microbiome Analysis Education and Recommendation Program in Improving Infant Gut Health
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childrens 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 studys 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 infants 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 surveysquestionnaires 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 infants life
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 studys 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 infants 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 surveysquestionnaires 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 infants life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None