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NCT05726396

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
University of Minnesota
~20 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:RMTPlacebo

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility and safety of RMT
Measured over 6 months after baseline

Conditions

Immune-related Colitis
Colitis

Explore related trials

Immune-Mediated ColitisSolid Neoplasm

NCT05726396

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Essentia Health Cancer Center

    Duluth, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health Deer River Clinic

    Deer River, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health Fosston

    Fosston, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health St. Joseph's Medical Center

    Brainerd, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health St. Mary's Detroit Lakes Clinic

    Detroit Lakes, Minnesotastudy coordinator listed

    Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ajay Prakash, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Ajay Prakash, MD, PhD
[email protected]
614-325-2088
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Localized, locally advanced or metastatic solid tumors who have received at least two doses of ICI (PD-1/PD-L1 with or without CTLA-4 inhibitor).
ICI used as a single agent, or combination or ICI in combination with other cytotoxic chemotherapy or targeted therapy for curative or palliative intent treatment.
Last ICI treatment with in 6 weeks of onset of IMDC symptoms
Meet one of the criteria for steroid refractory IMDC defined as:
Adequate organ function within 14 days prior to study enrollment defined as:
Well controlled diabetes with HbA1c of \<8 with in 6 months of screening
Euvolemic on physical examination
Stable vital signs at screening and enrollment that includes
Must be on standard antidiarrheal supportive care for at least 1 day prior to starting RMT. The regimen consists of: loperamide 2-4 mg every 6 hours (up to 16 mg /day) and/or diphenoxylate 5 mg/ atropine sulfate 0.05 mg (2 tabs or 10 ml) up to 4 times daily as needed. This will continue until resolution of diarrhea to NCI CTCAE v 5.0 Grade ≤ 1.
Age 18 years of age or older at the time of consent
Body weight of \>30 kg
Expected survival for at least 6 months in the opinion of the enrolling investigator as documented in the medical record
Voluntary written consent prior to the performance of any research related activity.

Exclusion

Diagnosis of concomitant infectious colitis based on standard stool screening including stool microscopy for ova and parasites, stool PCR for Clostridioides difficile, and locally available common enteric bacterial pathogen and viral panel by PCR.
Last cytotoxic chemotherapy or targeted therapy less than 3 week prior to screening
Patients anticipated to require cytotoxic chemotherapy or targeted therapy through the end of treatment EOT period (30 days following first dose of RMT)
Known current pregnancy or breastfeeding.
Receiving another investigational agent or has received an investigational agent within 60 days of study enrollment.
Any other uncontrolled Grade ≥3 infection at the time of enrollment (Concomitant systemic antibiotics for non-GI infections are allowed).
Previous documented history of chronic diarrhea from non-IMDC causes (For example: inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
Known dysphagia or inability to swallow study capsules (CTCAE v5 Dysphagia Grade ≥2 - symptomatic and altered eating/swallowing).
Known risk of aspiration based on history or current complaints.
Has a known sensitivity to any component of therapeutic agents used in this study.
On intravenous biologic agents for other baseline autoimmune conditions.
Other concomitant uncontrolled irAE's at the time of enrollment which would require systemic corticosteroids or biologic immunomodulatory agents.
On chronic systemic antibiotic therapy (antibiotics for ≥60 consecutive days within 12 weeks of enrollment).
Receipt of over-the-counter probiotics in the last 4 weeks
Receipt of live attenuated vaccination within 30 days of receiving RMT. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox (except shingrix), yellow fever, nasal seasonal flu, nasal H1N1 flu, rabies, BCG, and typhoid - COVID-19 vaccination is permitted.
Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.

What this trial measures

  • Feasibility and safety of RMT6 months after baseline

    Feasibility and safety of RMT as assessed by the occurrence of adverse events