What is restorative microbiota therapy (RMT) studying for immune-related colitis?

Restorative microbiota therapy (RMT) is being studied to assess its safety and feasibility in treating steroid-refractory immune checkpoint inhibitor-related colitis. Researchers want to understand if changing gut bacteria can help manage this condition when steroids are not effective. The study is led by the University of Minnesota and involves comparing RMT to a placebo.

Who may be eligible for this immune-related colitis clinical trial?

Adults 18 years or older with immune checkpoint inhibitor-related colitis that has not improved with steroid treatment may be eligible. Participants must have received at least two doses of immune checkpoint inhibitors and have adequate organ function. People who are pregnant, breastfeeding, or have active infections are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this immune-related colitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs associated with attending study visits.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05726396

Pilot Study Evaluating Safety and Feasibility of Oral Restorative Microbiota Therapy RMT for Steroid-Resistant Immune-Checkpoint Inhibitor-Related Colitis

Led by University of Minnesota · Updated on 2026-06-10

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and feasibility of oral restorative microbiota therapy RMT in patients experiencing steroid-refractory immune checkpoint inhibitor-related colitis IMDC. IMDC is a common side effect of immune checkpoint inhibitors used to treat solid tumors, causing significant discomfort and affecting quality of life. Current treatments include steroids and immunosuppressive agents, but data on these treatments for steroid-resistant cases is limited, and new options are needed. Evidence suggests that gut microbial diversity plays a role in both immune therapy effectiveness and side effects, and early case studies have shown promise for fecal microbiota transplant in refractory IMDC. Participants will be randomly assigned to receive either oral RMT capsules or placebo capsules. The RMT treatment involves a loading dose on day 1 with about 5 x 10 bacteria, followed by daily doses for 6 days containing 2 x 10 bacteria. Placebo capsules look identical and follow the same schedule. Capsules are self-administered on an empty stomach with water, and food can be eaten two hours after. This is a double-blind, randomized study lasting for 7 days of treatment with follow-up. During the study, participants will be monitored for safety and feasibility of RMT over 6 months. Researchers will assess clinical remission at days 10 and 30, and track the time to remission up to 180 days. Participants will undergo regular health evaluations, laboratory tests, and symptom assessments. The study will also monitor the impact of the treatment on participants immune-related colitis symptoms and overall condition throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older with localized, locally advanced, or metastatic solid tumors who have received at least two doses of immune checkpoint inhibitors (PD-1/PD-L1 with or without CTLA-4 inhibitor).
Last immune checkpoint inhibitor treatment received within 6 weeks before onset of immune-mediated diarrhea and colitis (IMDC) symptoms.
Meet criteria for steroid-refractory IMDC, including persistent symptoms after high-dose corticosteroids or biologic agents, or relapsed symptoms after steroid tapering.
Adequate organ function within 14 days before enrollment, including specific blood counts and liver and kidney function.
Well-controlled diabetes with HbA1c below 8 within 6 months before screening.
Stable vital signs including body temperature between 95.8 to 99.9°F, heart rate 60-100/min, and blood pressure 90-140/60-90 mm Hg.
On standard antidiarrheal supportive care for at least 1 day prior to starting treatment.
Body weight over 30 kg.
Expected survival of at least 6 months as assessed by the investigator.
Voluntary written informed consent prior to any study activities.

You will not qualify if you...

Active infectious colitis based on stool screening tests.
Cytotoxic chemotherapy or targeted therapy received less than 3 weeks prior to screening.
Anticipated need for cytotoxic chemotherapy or targeted therapy during the treatment period.
Current pregnancy or breastfeeding.
Receiving or recently received another investigational agent within 60 days.
Uncontrolled infections or other active immune-related adverse events requiring systemic treatment.
History of chronic diarrhea from non-IMDC causes such as inflammatory bowel disease.
Difficulty swallowing capsules or risk of aspiration.
Known sensitivity to study agents.
Use of intravenous biologic agents for other autoimmune conditions.
Use of chronic systemic antibiotics or over-the-counter probiotics recently.
Receipt of live attenuated vaccines within 30 days before treatment.
Psychiatric or social situations limiting compliance or informed consent ability.

Research Team

Ajay Prakash, MD, PhD

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Pilot Study Evaluating Safety and Feasibility of Oral Restorative Microbiota Therapy RMT for Steroid-Resistant Immune-Checkpoint Inhibitor-Related Colitis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria