Microbiome therapy for steroid-resistant immune colitis
Part of Digestive system clinical trials.
This Phase 2 pilot study tests a “restorative microbiota therapy” (RMT) to treat colitis caused by immune checkpoint inhibitors when standard treatments like steroids are not working. It aims to see if this approach is safe and practical, and may improve diarrhea and gut inflammation.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You’re at least 18 years old, weigh over 30 kg, and can take study capsules by mouth without swallowing problems.
- You’ve had at least two doses of immune checkpoint inhibitor treatment (with or without other cancer drugs) and your colitis symptoms started within the last 6 weeks.
- Your immune-related colitis has not improved enough after high-dose steroids and, if needed, a second biologic medicine (so it’s “steroid-refractory”).
- You must have had at least 1 day of standard anti-diarrhea medicines (like loperamide and/or diphenoxylate) before starting RMT, and keep them until diarrhea improves to mild (Grade 1 or less).
- You must not have an infection causing colitis, based on stool testing (including C. difficile) and standard stool panels.
- You need enough bone marrow, liver, and kidney function, have well-controlled blood sugar (HbA1c under 8), and be stable (vitals in range) at screening.
- You should not be pregnant or breastfeeding, and you must avoid other research drugs and live vaccines around the time of RMT.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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