Infant Restore: Efficacy of Microbiome Analysis and Education

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

• Microbiota
• Eczema
• Microbiome
• Gut Microbiome

Interventions

DIETARY_SUPPLEMENT

Tailored Recommendations

Based on the microbiome analysis, participants will receive personalized action plans. These plans include dietary, lifestyle, and supplemental suggestions to improve their infant's gut health.

BEHAVIORAL

Consult Call

Participants will have seven consult calls with a Gut Health Coach over the course of the study. These calls will provide guidance on the gut health reports, action plans, and any questions or concerns parents may have.

BEHAVIORAL

Email Series

Parents will receive a series of educational emails covering topics such as the importance of gut health, breastfeeding benefits, the impact of C-section delivery on the microbiome, and tips for introducing solid foods.

Sponsors & Collaborators

• Seeding, Inc DBA Tiny Health

  lead INDUSTRY

Principal Investigators

• Kimberley Sukhum, PhD · Seeding INC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Months

Max Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-04

Primary Completion

2025-04-14

Completion

2025-04-14

Countries

• United States

Study Locations