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NCT06609980 · ClinicalTrials.gov registry record · Phase 1
Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant
A Phase 1 study of Antibiotic Treatment, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06609980: Recruiting Phase 1 study of Antibiotic Treatment, sponsored by Rutgers, The State University of New Jersey.
NCT06609980 is a Phase 1 study of Antibiotic Treatment that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06609980, a Phase 1 study of Antibiotic Treatment, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 lifespa
Primary Outcome
Endpoints: Safety, defined as no/minimal serious adverse effects
Conditions Studied
Interventions
- DRUG autologous fecal matter transplant
Study Locations (1)
New Jersey
- Rutgers Department of Biochemistry & Microbiology - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 1 |
What NCT06609980 shows while recruiting
NCT06609980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Antibiotic Treatment appearing as the primary indexed condition, and to 1 intervention - of which autologous fecal matter transplant is the first listed.
NCT06609980 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06609980 about?
NCT06609980 is a clinical study titled "Restoration of Antibiotics Related Infant Microbiota Perturbations by Autologous Fecal Transplant". 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 ...
What is the current status of trial NCT06609980?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-08-01. Estimated completion is 2027-09-01.
What conditions does trial NCT06609980 study?
This clinical trial studies the following conditions: Antibiotic Treatment.
What interventions are being tested in trial NCT06609980?
The interventions under investigation include: autologous fecal matter transplant (DRUG).
Who is sponsoring clinical trial NCT06609980?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06609980 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06609980's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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