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Microbiota Therapy

RMT for Colitis

Phase 2
Waitlist Available
Led By Amit Kulkarni, MBBS
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after baseline

Summary

This trial is testing a new treatment for immune-related colitis caused by drugs used to treat cancer. The treatment involves restoring gut microbial diversity, and aims to improve the quality of life for those affected.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with microbiota therapies such as abdominal pain, bloating, changes in bowel habits, or infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
occurrence of adverse events
Secondary study objectives
Days for clinical remission
Primary efficacy of oral RMT in inducing clinical remission- Day 10
Primary efficacy of oral RMT in inducing clinical remission- Day 30

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RMT
2017
N/A
~20

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,436 Previous Clinical Trials
1,621,653 Total Patients Enrolled
1 Trials studying Colitis
26 Patients Enrolled for Colitis
Amit Kulkarni, MBBSPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

RMT (Microbiota Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05726396 — Phase 2
Colitis Research Study Groups: RMT group, active placebo
Colitis Clinical Trial 2023: RMT Highlights & Side Effects. Trial Name: NCT05726396 — Phase 2
RMT (Microbiota Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726396 — Phase 2
~20 spots leftby Jun 2025
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