RMT for Colitis

Recruiting in Palo Alto (17 mi)

Overseen byAmit Kulkarni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Minnesota

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with severe colitis caused by immune checkpoint inhibitors, who haven't improved after high-dose steroids or other immunosuppressives. They must have adequate organ function and have received at least two doses of ICI therapy within the past six months.

Inclusion Criteria

Patients must meet one of the criteria for steroid refractory IMDC as defined

My organs are functioning well enough for me to join the study.

Patients must be able to provide written consent prior to any research-related activities

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Exclusion Criteria

Known current pregnancy or breastfeeding

I have been treated for an infection in my colon.

Receiving or having received another investigational agent within 60 days of study enrollment

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Treatment Details

Interventions

Placebo (Other)
RMT (Microbiota Therapy)

Trial OverviewThe study tests oral restorative microbiota therapy (RMT) versus a placebo in managing steroid-refractory immune-mediated diarrhea and colitis (IMDC). It's a pilot randomized controlled trial to evaluate RMT's safety and feasibility.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RMT groupExperimental Treatment1 Intervention

16 patients will be randomized to Oral restorative microbiota therapy (RMT). Consenting eligible participants receive a loading dose of RMT capsules.

Group II: active placeboPlacebo Group1 Intervention

participants in the placebo arm will receive an identical looking placebo capsules