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Microbiome Therapy

Refined FMT for Ulcerative Colitis (REFOCUS Trial)

Phase < 1
Waitlist Available
Led By Ari Grinspan, MD
Research Sponsored by Ari M Grinspan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Permissible UC medications include oral or rectal administered mesalamines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

REFOCUS Trial Summary

This trial will study the safety and effectiveness of FMT therapy for UC patients, specifically looking at the gut bacteria Fusobacterium and Sutterella species. Subjects will be randomized to receive antibiotics before or not before FMT therapy.

Who is the study for?
Adults aged 18 to 75 with recently diagnosed Ulcerative Colitis (UC) can join this trial. They must have a documented UC diagnosis, active symptoms, and no recent steroid use. Participants need negative tests for certain GI infections and may be on specific UC medications.Check my eligibility
What is being tested?
The study is testing if swallowing capsules containing fecal matter from screened donors can treat UC. It also examines whether taking antibiotics like Vancomycin or Metronidazole before the transplant helps it work better compared to just the placebo.See study design
What are the potential side effects?
Potential side effects include digestive discomfort, allergic reactions, and infection risks due to introducing donor fecal material into the body. Antibiotics might cause nausea, diarrhea, or other gut issues.

REFOCUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can take mesalamines in the form of pills or as rectal suppositories.

REFOCUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with a severe adverse
Proportion of participants with an adverse
Secondary outcome measures
Albumin levels
C-reactive protein levels
Change in Nancy score
+6 more

REFOCUS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FMT with AntibioticsActive Control3 Interventions
Participants will receive antibiotics before receiving Fecal Microbiota Transplantation
Group II: FMT with placeboPlacebo Group2 Interventions
Participants will receive placebo before receiving Fecal Microbiota Transplantation

Find a Location

Who is running the clinical trial?

Ari M GrinspanLead Sponsor
Ari Grinspan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Refined Fecal Microbiota Transplantation (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04968951 — Phase < 1
Ulcerative Colitis Research Study Groups: FMT with Antibiotics, FMT with placebo
Ulcerative Colitis Clinical Trial 2023: Refined Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT04968951 — Phase < 1
Refined Fecal Microbiota Transplantation (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968951 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what demographics are individuals eligible to participate in this clinical experiment?

"This clinical trial seeks to enrol 20 volunteers aged between 18 and 75, who have been diagnosed with Ulcerative colitis for longer than 3 months prior. Notably, participants must exhibit a Partial Mayo score of 4-10 and an endoscopic subscore of at least 2 based on their flexible sigmoidoscopy results."

Answered by AI

How many individuals have participated in this clinical experiment?

"Affirmative. According to the data published on clinicaltrials.gov, this research is actively seeking out participants and was first advertised on 11/10/2021; with its most recent update arriving a year later. The goal is to enrol 20 patients from one single centre."

Answered by AI

What goals is this clinical trial attempting to accomplish?

"The primary measure of success for this trial, which will occur over the course of 8 Weeks, is assessing the proportion of participants that experience a severe adverse effect. Secondary evaluations consist of determining those with Mayo score 0 endoscopic remission, changes in Erythrocyte Sedimentation Rate (ESR), and Fecal Calprotectin levels."

Answered by AI

In what conditions might FMT with Antibiotics be utilized?

"FMT with Antibiotics is a common treatment for candidal vulvovaginitis. This same intervention can also be employed to manage trichomonas infections, dermatitis, and reduce the risk of postoperative infections."

Answered by AI

Are those aged sixty and older able to participate in this experiment?

"According to the stated requirements for this experiment, persons over 18 but under 75 are eligible to participate."

Answered by AI

Is participation in this trial still available for individuals?

"As per the details on clinicaltrials.gov, this medical trial is in the process of recruiting participants. This protocol was first published on November 10th 2021 and has been recently amended as of November 11st 2022."

Answered by AI
~1 spots leftby Mar 2025