Microbiome Analysis and Education for Gut Health

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seeding, Inc DBA Tiny Health

Must not be taking: Probiotics

Disqualifiers: Pre-existing gut conditions, immune conditions, congenital conditions, blood disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program of microbiome analysis, education, and tailored recommendations (personalized health advice) can improve gut health in infants delivered via C-section. Researchers are investigating whether this intervention can boost beneficial bacteria, reduce C-section-related risks, and lower the chance of future health issues like allergies. The trial will compare results from two groups: one receiving detailed gut health reports and action plans, and a control group receiving these after the trial. It seeks infants 0-3 months old, delivered by C-section, who haven't had probiotics.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on infant gut 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. It focuses on infants and their gut health, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that this microbiome analysis and education program is safe for infants?

Research has shown that treatments based on the gut microbiome, such as the personalized plans in this study, are usually well-tolerated. Studies have found that gut bacteria play a crucial role in health and can be influenced by diet and personalized treatments. This study aims to support the natural gut bacteria to improve health without introducing anything foreign to the body.

No direct evidence of harmful effects from microbiome treatments appears in the available sources. However, it is important to note that this study is in the early stages, labeled as "Not Applicable." While the treatment is expected to be safe based on existing knowledge, detailed safety data from this study is not yet available.

Overall, microbiome treatments, like those in this study, are considered safe for most people. This approach aims to improve gut health through personalized plans and education, reducing risks compared to more invasive treatments. Participants should discuss any concerns with the researchers or their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on personalized education to enhance gut health, particularly in infants. Unlike standard probiotic or dietary treatments that offer a one-size-fits-all approach, this trial emphasizes tailored recommendations based on individual microbiome analysis. This personalized strategy aims to provide more effective and specific guidance for improving gut health, potentially leading to better outcomes and understanding of how the microbiome influences overall well-being.

What evidence suggests that this microbiome analysis and education program is effective for improving gut health in infants?

Research has shown that personalized diets can improve gut health. For example, specific dietary changes can increase the production of short-chain fatty acids (SCFAs), which benefit the gut. One study found that personalized granola increased SCFA production and improved mood, suggesting that customized diets can enhance gut bacteria. In this trial, participants in the intervention arm will receive tailored recommendations to improve their infant's gut health. Although evidence indicates that diet affects gut bacteria, the effectiveness of gut health tests remains debated. Overall, targeted dietary changes may help improve gut health and potentially lower future health risks. ^{6 7 8 9 10}

Who Is on the Research Team?

Kimberley Sukhum, PhD

Principal Investigator

Seeding INC

Are You a Good Fit for This Trial?

This trial is for infants aged 0-3 months who were delivered via Cesarean section. It aims to help parents improve their child's gut health and reduce future health risks through microbiome analysis and education.

Inclusion Criteria

My baby was born through a C-section.

My baby is between 0 to 3 months old.

Exclusion Criteria

Infants who are not residents of the United States with US postal service

Infants who have been given probiotic supplements in their life at recruitment

My infant has a pre-existing gut condition like Hirschsprung disease or EoE.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive microbiome reports, personalized action plans, and educational materials over six months

6 months

2 visits (in-person) for stool sample collection, ongoing virtual engagement via app and email

Control

Participants in the control arm receive microbiome results and educational materials after the study's completion

6 months

Follow-up

Participants are monitored for changes in microbiota composition and symptoms influenced by gut microbiome

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Recommendations

Trial Overview The study tests if personalized recommendations based on microbiome analysis, along with educational support, can positively impact an infant's gut health compared to just receiving this information after the study ends.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 3 Interventions

Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.

Group II: Control Active Control 1 Intervention

Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.

Who Is Running the Clinical Trial?

Seeding, Inc DBA Tiny Health

Lead Sponsor

Trials

2

Recruited

130+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280474/

Towards Tailored Gut Microbiome-Based and Dietary ... We review current scientific evidence for the impact of early life environmental factors, including diet, on gut microbiota and neuro-development.

2. mankatofreepress.com mankatofreepress.com/news/lifestyles/jury-is-out-on-effectiveness-of-gut-health-tests/article_0b01e3d7-7389-4725-92bd-c3f96dac536f.html

Jury is out on effectiveness of gut health tests | Lifestyles Research shows a healthy gut microbiome may play a role in preventing things like liver disease and diabetes and could even influence mental ...

3. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2025.1607918/full

Effectiveness of personalized granola tailored to the gut ... Personalized granola enhances SCFA production and improves mood, suggesting that dietary interventions tailored to gut microbiota composition may optimize ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12332753/

Effectiveness of personalized granola tailored to the gut ... Personalized granola enhances SCFA production and improves mood, suggesting that dietary interventions tailored to gut microbiota composition ...

5. microbiomejournal.biomedcentral.com microbiomejournal.biomedcentral.com/articles/10.1186/s40168-024-01975-x

Tailored impact of dietary fibers on gut microbiota - Microbiome This in vitro study suggests that incorporating apple fibers into the diets of obese individuals can help modify the composition of gut bacteria and improve ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40991166/

Microbiome-based approaches to personalized nutrition Recent findings demonstrate how the microbiota is significantly shaped by diet and how the microbiome in turn influences how each person reacts ...

7. nature.com nature.com/articles/s41467-024-51651-9

Gut Microbiome Wellness Index 2 enhances health status ... Recent advancements in translational gut microbiome research have revealed its crucial role in shaping predictive healthcare applications.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282321/

Assessing the safety of microbiome perturbations - PMC Gut microbiome states have also been associated with long-term incident disease and mortality risk [58,59]. However, determining if gut microbiota perturbations ...

9. gut.bmj.com gut.bmj.com/content/73/11/1893

What defines a healthy gut microbiome? Some experts define a healthy gut from a functional or clinical viewpoint, considering it as not having any diagnosed digestive diseases or disorders.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2772431X22000375

Correlation between human gut microbiome and diseases Human gut microbiome is a major source of human bacterial population and a significant contribution to both positive and harmful effects.