NCT06609980 Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant
| NCT ID | NCT06609980 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Antibiotic Treatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Antibiotics are lifesaving therapeutic drugs which have been used by adults, children, and infants alike for decades. There is an increase in global use of antibiotics over the course of lifetime and earlier in lifetime, with some countries recording as high as 12 courses a year in children younger than two. While antibiotics are successful in eradicating many pathogenic bacteria, research has demonstrated significant effect on beneficial gut microbiota, including long-lasting shift in the dynamics, composition, richness, and maturity of the intestinal flora. Microbiota alterations during early life, including through antibiotics use as well as birth via C-section, constitute a developmental perturbation, which increases the risk of modern diseases of immune and metabolic dysfunction. Strong epidemiological evidence suggests associations between early stressors of the microbiota and a number of common diseases, such as obesity, asthma, allergies, celiac disease, and Type 1 Diabetes. Furthermore, excess antibiotic exposure is associated with the development of neurological and psychiatric disorders. Currently, no strategies exist to restore the microbiome other than reliance on spontaneous repair mechanism, which often takes months in a healthy individual barring further antibiotic exposure. Contrary to popular belief, ingestion of probiotics, particularly after antibiotics, has been demonstrated to slow down the repair as it introduces an exogenous and massive amounts of only a few types of bacterial strains into a finely-tuned ecosystem of hundreds of different strains. It is hypothesized that by preserving the child's microbiome prior to antibiotic therapy and reintroducing it afterwards through an autologous fecal matter transplant (FMT) will assist in a quick, effective, and host-specific microbiome recolonization to the levels and patterns to those prior to antibiotics. This would in turn reduce the overall loss of microbiome diversity over the child's lifespan, essentially providing a 'reset' option to the child's most unadulterated version of microbiome. This approach utilizes delivering the sample by mixing it in maternal milk or formula and feeding it to the child through a bottle, which can be performed anywhere without any discomfort for the child.
Eligibility 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
Contact & Investigator
Maria Gloria Dominguez-Bello, PhD
PRINCIPAL INVESTIGATOR
Rutgers Department of Biochemistry & Microbiology
Frequently Asked Questions
Who can join the NCT06609980 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 4 Years, studying Antibiotic Treatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06609980 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06609980 currently recruiting?
Yes, NCT06609980 is actively recruiting participants. Contact the research team at md1360@sebs.rutgers.edu for enrollment information.
Where is the NCT06609980 trial being conducted?
This trial is being conducted at New Brunswick, United States.
Who is sponsoring the NCT06609980 clinical trial?
NCT06609980 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Maria Gloria Dominguez-Bello, PhD at Rutgers Department of Biochemistry & Microbiology. The trial plans to enroll 100 participants.