A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patie… (NCT05726396) | Clinical Trial Compass
WithdrawnPhase 2
A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis
Stopped: The trial has been on hold due to inability to finalize product procurement and testing through the FDA
United States0Started 2025-09-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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 addition to corticosteroids (with starting dose of prednisone or equivalent ≥1 mg/kg/day for at least 48 hours followed by receipt of at least one dose of either a TNFα inhibitor or an anti- integrin for at least 48 hours or
✓. For patients with relapsed IMDC who have discontinued steroids: Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) within 4 weeks of discontinuing prednisone or equivalent. These patients should have received initial high-dose corticosteroid therapy (˃1 mg/kg/day prednisone or equivalent) with subsequent taper over at least 4 weeks or
✓. For patients with relapsed IMDC following the tapering of steroids Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) while the prednisone taper is on-going. These patients should have received initial high-dose corticosteroid therapy (˃1 mg/kg/day prednisone or equivalent) with resulting clinical resolution of diarrhea (NCI CTCAE v 5.0 Grade ˂ 1 diarrhea) for at least 24 hours before relapse
✓. Hepatic function: Total bilirubin ≤ 1.5x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤5x ULN)
✓. Renal function: measured creatinine clearance \>40 mL/min or estimated glomerular filtration rate (GFR) \>40 mL/min If AST/ALT and serum creatinine elevation are suspected to be irAEs, patients are eligible as long as the irAE are controlled (i.e. not getting worse at the time of enrollment)