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Immune-related ColitisPhase 2NCT05726396

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

A Phase 2 study testing RMT in people with Immune-related Colitis and Colitis, run by University of Minnesota at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immune-related Colitis, Colitis
What is being tested?
RMT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
9 sitesUnited States
Study dates
23 Sep 2025to 1 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Persistent symptoms (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) following high-dose corticosteroid therapy (≥1 mg/kg/day prednisone or equivalent) for least 48 hours or
  • Persistent symptoms (ongoing Grade ≥ 2 diarrhea per CTCAE v5.0.) following use of a one or more biologic agent (i.e. either a TNFα inhibitor or an anti-integrin) in addition to corticosteroids (with starting dose of prednisone or equivalent ≥1 mg/kg/day for at least 48 hours followed by receipt of at least one dose of either a TNFα inhibitor or an anti- integrin for at least 48 hours or
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  • For patients with relapsed IMDC who have discontinued steroids: Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) within 4 weeks of discontinuing prednisone or equivalent. These patients should have received initial high-dose corticosteroid therapy (˃1 mg/kg/day prednisone or equivalent) with subsequent taper over at least 4 weeks or
  • For patients with relapsed IMDC following the tapering of steroids Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) while the prednisone taper is on-going. These patients should have received initial high-dose corticosteroid therapy (˃1 mg/kg/day prednisone or equivalent) with resulting clinical resolution of diarrhea (NCI CTCAE v 5.0 Grade ˂ 1 diarrhea) for at least 24 hours before relapse
  • Adequate organ function within 14 days prior to study enrollment defined as:
  • Hematology: Hemoglobin ≥9.0 g/dL, absolute neutrophil count (ANC) ≥1,000/mcL, platelets ≥75,000/mcL,
  • Hepatic function: Total bilirubin ≤ 1.5x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤5x ULN)
  • Renal function: measured creatinine clearance >40 mL/min or estimated glomerular filtration rate (GFR) >40 mL/min If AST/ALT and serum creatinine elevation are suspected to be irAEs, patients are eligible as long as the irAE are controlled (i.e. not getting worse at the time of enrollment)
  • 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
  • Body temperature 95.8 to 99.9°F
  • Heart rate between 60-100/min
  • Blood pressure 90-140/60-90 mm of Hg.
  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ajay Prakash, MD, PhD contact

614-325-2088

praka086@umn.edu

9 sites in 1 country

United States9 sites, 9 recruiting

  • Essentia Health St. Joseph&#39;s Medical Center

    Brainerd, Minnesota, 56401

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health Deer River Clinic

    Deer River, Minnesota, 56636

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health St. Mary's Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health Fosston

    Fosston, Minnesota, 56542

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Ajay Prakash, MD, PhD, 614-325-2088, praka086@umn.edu

    Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

    Bret Friday, MD, 218-786-3308, CancerTrials@EssentiaHealth.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
RMT, Placebo
Medical subject headings
Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RMTDrug

    A single loading dose of RMT capsules containing ~5 x 10 11 bacteria on day 1 followed by 2 x 10 11 bacteria daily for 6 days. The RMT capsule preparation (~2-5 capsules, size 00) is self-administered on an empty stomach with at least one glass of water. Clear liquids are allowed, and food can be resumed 2 hours after administration.

  • PlaceboDrug

    Participants will receive an identical looking placebo capsules daily for 7 days (i.e 5 placebo capsules on day 1), followed by 2 placebo capsules daily from Day 2-7. The placebo capsule preparation is self-administered on an empty stomach with at least one glass of water. Clear liquids are allowed, and food can be resumed 2 hours after administration.

Study groups in NCT05726396
Study groupRoleWhat they receive
RMT groupExperimental16 patients will be randomized to Oral restorative microbiota therapy (RMT). Consenting eligible participants receive a loading dose of RMT capsules.
Receives: Drug: RMT
active placeboPlacebo comparatorparticipants in the placebo arm will receive an identical looking placebo capsules
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and safety of RMT

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

    Measured: 6 months after baseline

Secondary outcomes (3)

  1. Clinical remission by Day 10

    Proportion of patients who experience diarrhea resolution to Grade <= 1 of refractory IMDC at Day 10 from 1st dose of RMT

    Measured: Day 10

  2. Clinical remission by Day 30

    Incidence of clinical remission of refractory IMDC at Day 30 following first dose of RMT

    Measured: Day 30

  3. Time for clinical remission

    Days to induce a clinical remission of refractory IMDC necessary to achieve a diarrhea of Grade <= 1

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start23 Sep 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726396
Sponsor's protocol ID
MNCCTN025
Status last verified
Jun 2026
First submitted
4 Feb 2023
Last updated
10 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RMT in people with Immune-related Colitis and Colitis, run by University of Minnesota at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ajay Prakash, MD, PhD (614-325-2088, praka086@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and safety of RMT (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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