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Probiotics

Microbiome Analysis and Education for Gut Health

N/A
Waitlist Available
Led By Kimberley Sukhum, PhD
Research Sponsored by Seeding, Inc DBA Tiny Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants aged 0 to 3 months at time of enrollment
Be younger than 18 years old
Must not have
Infants who are not full term or less than 36-weeks gestation at delivery
Infants with pre-existing gut conditions (Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) such as eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a program focusing on analyzing and improving the gut microbiome of infants delivered via Cesarean section can enhance gut health, decrease health risks, and empower parents. The study

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve non-invasive procedures like stool sample collection, tailored recommendations, consult calls, and email series for education, there are no direct side effects associated with typical medical treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is between 0 to 3 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My baby was born before 36 weeks of pregnancy.
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My infant has a pre-existing gut condition like Hirschsprung disease or EoE.
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My infant has a congenital condition like cleft lip/palate or Down syndrome.
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My infant has a blood disorder like sickle cell, thalassemia, or hemophilia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Microbiota composition
Secondary study objectives
Atopic march signature
C-section signature
Other study objectives
Educational
Gut reacted symptoms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment3 Interventions
Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.
Group II: ControlActive Control1 Intervention
Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.

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Who is running the clinical trial?

Seeding, Inc DBA Tiny HealthLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Kimberley Sukhum, PhDPrincipal InvestigatorSeeding INC
~17 spots leftby Apr 2025
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