Fecal microbiota transplantation for Ulcerative Colitis

Phase-Based Progress Estimates
Hamilton Health Sciences, Hamilton, CanadaUlcerative ColitisFecal microbiota transplantation - Biological
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new combination therapy for UC that may be more effective than existing treatments.

Eligible Conditions
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Week 6

Week 6
Adverse events
Clinical remission
Clinical response
Endoscopic improvement
Fecal microbiome
Mucosal microbiome

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Donors Feces
8%abdominal pain
8%fecal urgency
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03378921) in the Donors Feces ARM group. Side effects include: fever with 8%, abdominal pain with 8%, fecal urgency with 8%.

Trial Design

1 Treatment Group

FMT and vedolizumab
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Fecal microbiota transplantation · No Placebo Group · Phase 4

FMT and vedolizumab
Experimental Group · 1 Intervention: Fecal microbiota transplantation · Intervention Types: Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6

Who is running the clinical trial?

McMaster UniversityLead Sponsor
820 Previous Clinical Trials
1,731,743 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
860 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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Frequently Asked Questions

Is this clinical trial a pioneer endeavor in its field?

"To date, 23 clinical trials for Fecal microbiota transplantation are in progress across 312 cities and 42 countries. An inaugural experiment was initiated by Takeda back in 2015 with 260 participants to reach the final phase of drug approval; since then 40 such studies have been completed." - Anonymous Online Contributor

Unverified Answer

How many participants are the maximum that can join this trial?

"Affirmative. According to clinicaltrials.gov, the search for participants is currently ongoing and has been since May 1st 2021. The trial was recently updated on August 23rd 2022 and 10 people are sought from a single site." - Anonymous Online Contributor

Unverified Answer

Is this examination currently recruiting participants?

"Clinicaltrials.gov indicates that this trial is actively seeking subjects, with the study first announced on May 1st 2021 and revised as recenty as August 23rd 2022." - Anonymous Online Contributor

Unverified Answer

Has the FDA authorized Fecal microbiota transplantation for medical use?

"Fecal microbiota [transplant](https://www.withpower.com/clinical-trials/transplant)ation is approved for medical use and has been sufficiently studied, so it was assigned a safety rating of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.