Tailored Recommendations for Infant Gut Microbiome
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.
Researchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.
Participants will:
1. Provide six microbiome stool samples over a 24-month period.
2. Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.
3. Receive microbiome reports and guidance according to their assigned study arm.
4. Complete surveys on infant health history, symptoms, diet, and environmental exposures.
5. Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.
This study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.
Who Is on the Research Team?
Qian Yuan, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for infants aged 0-3 months who were delivered via Cesarean section. The study aims to see if analyzing and improving their gut microbiome can help prevent immune-related conditions like eczema. Infants will be monitored over a 24-month period, with parents providing stool samples and completing health surveys.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Consult Call
- Educational Email Series
- Tailored Recommendations
Trial Overview
The trial tests whether personalized microbiome analysis, coaching, and educational materials can benefit infant gut health compared to minimal intervention or no immediate feedback. It explores the impact on beneficial bacteria levels, pathogen reduction, and potential improvements in skin conditions related to allergies.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner.
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
Participants in the control arm will provide the same level of microbiome and survey data as the intervention arms but will not see their results until after the completion of the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seeding, Inc DBA Tiny Health
Lead Sponsor
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