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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2026

Conditions
Immune-related ColitisColitis
Interventions
DRUG

RMT

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.

DRUG

Placebo

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.

Trial Locations (9)

55072

RECRUITING

Essentia Health Sandstone, Sandstone

55414

RECRUITING

University of Minnesota, Minneapolis

55746

RECRUITING

Essentia Health Hibbing Clinic, Hibbing

55792

RECRUITING

Essentia Health Virginia Clinic, Virginia

55805

RECRUITING

Essentia Health Cancer Center, Duluth

56401

RECRUITING

Essentia Health St. Joseph's Medical Center, Brainerd

56501

RECRUITING

Essentia Health St. Mary's Detroit Lakes Clinic, Detroit Lakes

56542

RECRUITING

Essentia Health Fosston, Fosston

56636

RECRUITING

Essentia Health Deer River Clinic, Deer River

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT05726396 - A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis | Biotech Hunter | Biotech Hunter