A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) i
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, oth
| Condition(s) | Immune-related Colitis, Colitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. Prelimin |
| Who can participate | Inclusion Criteria: * Localized, locally advanced or metastatic solid tumors who have received at least two doses of ICI (PD-1/PD-L1 with or without CTLA-4 inhibitor). * ICI used as a single agent, or combination or ICI in combination with other cytotoxic chemotherapy or targeted therapy for curative or palliative intent treatment. * Last ICI treatment with in 6 weeks of onset of IMDC symptoms * Meet one of the criteria for steroid refractory IMDC defined as: 1. Persistent symptoms (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) following high-dose corticosteroid therapy (≥1 mg/kg/day prednisone or equivalent) for least 48 hours or 2. Persistent symptoms (ongoing Grade ≥ 2 diarrhea per CTCAE v5.0.) following use of a one or more biologic agent (i.e. either a TNFα inhibitor or an anti-integrin) in add |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Minnesota |
| Locations | Brainerd, Minnesota, United States; Deer River, Minnesota, United States; Detroit Lakes, Minnesota, United States; Duluth, Minnesota, United States; Fosston, Minnesota, United States; Hibbing, Minnesota, United States (+3 more sites) |
| Start date | 2025-09-23 |
| NCT ID | NCT05726396 |
| Official listing | https://clinicaltrials.gov/study/NCT05726396 |