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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
occurrence of adverse events
Secondary outcome measures
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
1,378 Previous Clinical Trials
1,588,479 Total Patients Enrolled
Amit Kulkarni, MBBSPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for an infection in my colon.I have an active inflammatory bowel disease.I have a history of chronic diarrhea not caused by infection.I have moderate to severe difficulty swallowing.I have a history or current issues with choking on food or liquids.My organs are functioning well enough for me to join the study.I do not have any severe infections that are not under control.I've had 2 doses of immune therapy for my cancer and steroids didn't help my side effects.
Research Study Groups:
This trial has the following groups:- Group 1: RMT group
- Group 2: active placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could potential participants still join this experiment?
"The information located on clinicaltrials.gov reports that this particular research trial is not currently accepting patients, as it was last updated in February 4th 2023. However, there are 210 other trials actively enrolling volunteers at the moment."
Answered by AI
Has the FDA formalized its endorsement of RMT group?
"Our team at Power has rated the safety of RMT group as a 2 due to its status as a Phase 2 trial. This means there is some evidence backing up its safety, but no data confirming efficacy."
Answered by AI
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