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NCT05726396 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis
A Phase 2 study, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT05726396 is a Phase 2 study that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 20 participants.
The verdict
NCT05726396, a Phase 2 study, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL). Steroids are the first line of treatment for severe ICI induced Immune- mediated diarrhea and colitis (IMDC). If there is no improvement in 48 to 72 hours, other immunosuppressive agents (infliximab, vedolizumab) are recommended. However, efficacy data supporting the use of immunosuppressives for steroid refractory IMDC is limited by case reports/series. Clinical trials focusing on steroid-refractory colitis are sparse. Novel treatments for IMDC outside of blanket immunosuppression are needed. There is robust evidence to suggest that gut microbial diversity and composition is associated with both ICI efficacy and toxicity. Preliminary studies have shown that pathophysiology of immune mediated colitis may be related to loss of gut microbial diversity. Recently, multiple case series have shown the utility of fecal microbiota transplant for treatment of refractory IMDC providing the proof of concept. This is a pilot randomized placebo controlled study to assess the safety and feasibility of oral restorative microbiota therapy (RMT) in patients with steroid- refractory IMDC.
Interventions
- DRUG Placebo
- DRUG RMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-23 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05726396
The ClinicalTrials.gov registry entry for NCT05726396 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05726396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05726396 about?
NCT05726396 is a clinical study titled "A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis". Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL). Steroids are the first line of treatment for severe ICI induced Immune- mediated diarrhea and colitis (IMDC). If there is no improvement in...
What is the current status of trial NCT05726396?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-09-23. Estimated completion is 2027-02-01.
What interventions are being tested in trial NCT05726396?
The interventions under investigation include: Placebo (DRUG), RMT (DRUG).
Who is sponsoring clinical trial NCT05726396?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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