Restoring gut health in infants after antibiotic use with fecal transplants
Official title: Fecal Microbiota Transplantation (Autologous) in Infants Treated With Antibiotics
Run by Rutgers, The State University of New Jersey · NCT06609980 · Data updated 2026-11-12
This study is testing whether giving healthy poop from the same child back to infants and toddlers who have taken antibiotics can help restore their gut health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 1 Month to 4 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | August 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT06609980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy infants and toddlers aged 1 month to 4 years who have not received antibiotics in the past 3 months.
✕Probably not a fit
Patients who have documented immunological conditions or have used antibiotics within the last 3 months will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of autologous fecal matter transplants in healthy infants and toddlers aged 1 month to 4 years who have experienced antibiotic treatment. The intervention seeks to restore the beneficial gut microbiota that may have been disrupted by antibiotics, which can lead to various health issues later in life. By analyzing the changes in microbiota composition and health outcomes, the study hopes to provide insights into mitigating the negative impacts of early antibiotic exposure. The research is being conducted at Rutgers University, focusing on the importance of gut health in early childhood development.
Why it matters
Potential benefit: If successful, this approach could help restore healthy gut microbiota in infants, potentially reducing the risk of developing immune and metabolic disorders later in life.
How similar studies have gone: While the use of fecal transplants has shown promise in other populations, this specific approach in infants following antibiotic treatment is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy infants and toddlers 1 month to 4 years of age (regardless of birth mode, sex, or diet (breastmilk, formula, solids, etc.) Exclusion Criteria: * Child's antibiotic use within 3 months before inclusion in the study * Documented immunological condition from the child's pediatrician
Where it's running
-
Rutgers Department of Biochemistry & Microbiology
New Brunswick, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Maria Gloria Dominguez-Bello, PhD — Rutgers Department of Biochemistry & Microbiology
- Study coordinator: Maria Gloria Dominguez-Bello, PhD
- Email: md1360@sebs.rutgers.edu
- Phone: 848-932-5648
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.