NCT05726396 is a Phase 2 clinical trial of RMT in Immune-related Colitis, sponsored by University of Minnesota.

Who is sponsoring NCT05726396?

NCT05726396 is sponsored by University of Minnesota.

What drugs are being tested in NCT05726396?

Interventions in NCT05726396: RMT, Placebo.

What condition does NCT05726396 study?

NCT05726396 studies Immune-related Colitis, Colitis.

Is NCT05726396 still recruiting?

NCT05726396 is currently withdrawn. Last updated 20 February 2026.

Last reviewed 2026-02-20 · How we verify

NCT05726396

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 2 Last updated 20 February 2026

What this trial tests

Phase 2 trial testing RMT in Immune-related Colitis. Withdrawn.

Timeline

23 September 2025

Primary endpoint
1 February 2026

1 February 2026

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Start date	23 September 2025
Primary completion	1 February 2026
Estimated completion	1 February 2026
Sites	9 locations across United States

Drugs / interventions tested

RMT — full drug profile →
Placebo

Conditions studied

Immune-related Colitis — all drugs for Immune-related Colitis →
Colitis — all drugs for Colitis →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Immune-related Colitis or Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Rheumatic adverse events of immune checkpoint inhibitors in cancer immunotherapy.
Abdel-Wahab N, Suarez-Almazor ME. · · 2024 · cited 4× · PMID 38400840 · DOI 10.1080/1744666x.2024.2323966
Steroid-sparing strategies for managing immune-related adverse events.
Huang JJ, YousefiAsl M, Singh N, Grivas P, et al · · 2026 · cited 1× · PMID 41545303 · DOI 10.1136/jitc-2025-013776

Verify or expand the search:

Other trials of RMT

Trials testing the same drug.

NCT03313284 — Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects? · NA · completed

Other University of Minnesota trials

Trials by the same sponsor.

NCT02421497 — MRI Technical Development and Applications in Kidney Disease · not yet recruiting
NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05726396 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 20 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05726396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing