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Fecal Microbiota Transplant for Ulcerative Colitis
Phase 2
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
18 years of age or older but less than 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing whether a certain kind of massage therapy is safe and effective for people with ulcerative colitis who are also taking vedolizumab or ustekinumab.
Who is the study for?
This trial is for adults aged 18-75 with ulcerative colitis, confirmed by a doctor using standard tests. Participants must have active symptoms and be starting vedolizumab or ustekinumab treatment but can't have used certain medications recently. Women who can bear children must use contraception during the trial.Check my eligibility
What is being tested?
The study is testing LFMT against a placebo in patients beginning biologic treatments for ulcerative colitis to see which is safer and more effective. Patients will either receive this new fecal microbiota therapy or a dummy treatment as they start their prescribed medication.See study design
What are the potential side effects?
While specific side effects of LFMT are not listed here, similar treatments may cause digestive discomfort, bloating, cramps, nausea or diarrhea. Any intervention could also potentially lead to allergic reactions or infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcerative colitis was confirmed by a doctor using specific tests.
Select...
I am between 18 and 75 years old.
Select...
My ulcerative colitis is active, with a moderate to severe score and extends beyond 15 cm from the anal verge.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
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 serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).
Secondary outcome measures
Changes in inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) over time up to week 24 in each group
Changes in partial Mayo score over time up to week 24 relative to baseline in each group
Changes in quality of life, assessed by short IBD Questionnaire (sIBDQ), and work productivity, assessed by Work Productivity and Activity Impairment Questionnaire (WPAIQ), at week 8 and 24 relative to baseline in each group
+6 moreOther outcome measures
Changes in stool microbiome at time of remission relative to baseline in each group
Changes in stool microbiome at week 8 and 24 relative to baseline in each group
Proportion of participants with Corticosteroid-free remission at week 8 and 24
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LFMT capsules + vedolizumabExperimental Treatment1 Intervention
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
Group II: LFMT capsules + ustekinumabExperimental Treatment1 Intervention
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
Group III: Placebo capsules + vedolizumabPlacebo Group1 Intervention
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.
Group IV: Placebo capsules + ustekinumabPlacebo Group1 Intervention
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,094 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
1,089 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had treatment for C. difficile or other gut infections in the last 4 weeks.My doctor has chosen vedolizumab or ustekinumab for my treatment.I have used vedolizumab within the last 8 weeks.My condition is diagnosed as indeterminate colitis.My ulcerative colitis was confirmed by a doctor using specific tests.My white blood cell count is high and I have had a fever over 38°C.I have not used any rectal or topical treatments in the last 2 weeks.I have used adalimumab or infliximab within the last 8 weeks.I have been hospitalized for severe ulcerative colitis.I have not taken antibiotics in the last 30 days and do not expect to need any during the study.I am between 18 and 75 years old.I have not had abdominal surgery in the last 60 days.I have not had a fecal microbiota transplant in the last 3 months.I have never used biologic drugs or they did not work for me.I have not taken tofacitinib in the last 4 weeks.I take more than 30 mg of prednisone daily.I have not used ustekinumab in the last 12 weeks.I haven't taken cyclosporine, tacrolimus, or thalidomide in the last 4 weeks.My ulcerative colitis is active, with a moderate to severe score and extends beyond 15 cm from the anal verge.
Research Study Groups:
This trial has the following groups:- Group 1: LFMT capsules + vedolizumab
- Group 2: Placebo capsules + vedolizumab
- Group 3: LFMT capsules + ustekinumab
- Group 4: Placebo capsules + ustekinumab
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.
Are there any restrictions on who is allowed to enroll in this trial?
"The requirements to participate in this clinical trial are that patients must have an ulcer and be between 18-75 years old. Presently, the researchers conducting the study are looking for approximately 40 individuals who fit these qualifications."
Answered by AI
What are some of the risks associated with LFMT?
"Lyophilized fecal microbiota (LFMT) received a score of 2 for safety. This is due to the lack of efficacy data, as this is only a Phase 2 trial."
Answered by AI
Are patients still being enrolled in this clinical trial?
"The study is recruiting patients, according to the most recent information available on clinicaltrials.gov. This page was created on 6/3/2022 and last updated 7/6/2022."
Answered by AI
Are adolescent patients eligible for this research?
"According to the information published on clinicaltrials.gov, individuals aged 18-75 are eligible for this particular trial. There are 71 other trials available for patients that are underaged and 363 different options for senior citizens."
Answered by AI
How many people are recruited for this investigation?
"The latest information on clinicaltrials.gov stipulates that this trial is currently seeking enrolment from willing participants. The posting date was June 3rd, 2022 and has been edited as recently as July 6th, 2022. As of now, the team conducting the trial needs 40 individuals at a single site."
Answered by AI
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