Tailored Recommendations for Infant Gut Microbiome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if personalized microbiome recommendations can enhance gut health and reduce the risk of immune problems in infants born by C-section. Researchers will assess how well these tailored recommendations increase beneficial bacteria and decrease harmful ones. The trial will compare three groups: one receiving full microbiome reports and coaching, another receiving basic recommendations, and a control group that will see results only after the trial concludes. Infants eligible for this study are those born via C-section and have not used probiotics.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve infant health.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. However, it does exclude infants who have been given probiotic supplements.
What prior data suggests that these interventions are safe for infants?
Research shows that personalized probiotics can help reduce health risks for infants. For instance, one study found that giving personalized probiotics to infants might lower the risk of eczema by 83%. This suggests that customized support for gut health is promising and generally well-tolerated in young children.
Although specific studies on the safety of personalized gut health recommendations in this trial are lacking, probiotics and personalized nutrition have been shown to be safe in other contexts. Past research indicates that probiotics are usually safe for infants, especially when administered in a controlled and personalized manner.
This trial is labeled as "Not Applicable" for phase, indicating it likely involves non-invasive and low-risk methods, focusing on diet and education rather than new drugs. Participants can expect the interventions to be safe and well-tolerated.
Overall, evidence suggests that personalized recommendations for improving gut health in infants are safe and could lead to better health outcomes.12345Why are researchers excited about this trial?
Researchers are excited about the tailored recommendations for infant gut microbiome because they offer a personalized approach to enhancing gut health, which is unlike traditional one-size-fits-all probiotic treatments. The full intervention provides interactive microbiome reports, personalized coaching, and educational materials, allowing for a more customized and engaging experience. The limited intervention also stands out by offering basic recommendations with the option for personalized report interpretation with a Nurse Practitioner, which could lead to more precise and effective dietary adjustments. This trial seeks to understand how tailored strategies can optimize infant gut health, potentially leading to more effective and individualized care.
What evidence suggests that this trial's treatments could be effective for improving gut health in C-section infants?
Research has shown that a personalized microbiome program can positively change the gut bacteria of babies born by C-section. This trial will compare different levels of intervention to assess their impact on infant gut health. Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials. Meanwhile, the limited intervention arm will receive simplified reports with basic probiotic recommendations and the option for report interpretation calls. One study found that giving personalized probiotic advice early in life could lower the risk of eczema by 83%. These findings suggest that customized microbiome support can improve gut health and may help prevent early signs of immune-related issues. Such approaches rely on the idea that a balanced gut microbiome can support a healthier immune system.25678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive microbiome reports, coaching, personalized recommendations, and educational materials according to their assigned study arm
Follow-up
Participants are monitored for changes in gut microbiota composition and health outcomes
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
Citations
Improving immune‐related health outcomes post‐cesarean ...
Conclusion. A personalized microbiome‐based program can modulate the gut microbiome of C‐section‐born infants and may reduce the risk of atopic ...
2.
nutraingredients.com
nutraingredients.com/Article/2025/10/15/us-infant-microbiome-study-links-personalized-probiotics-to-83-lower-eczema-risk/US infant microbiome study links personalized probiotics to ...
Personalized probiotic recommendations in early infancy may significantly reduce eczema risk, suggests a new study from Tiny Health.
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