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First received: February 04, 2023

Clinical Trial: A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Immune-related Colitis

Study Type: INTERVENTIONAL


Official Title: A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis

Brief 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…

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