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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

Must not have

Indeterminate colitis

Peripheral white blood cell count > 35.0 x 109/L and fever (>38 degrees Celsius)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

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.

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.

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 below

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My ulcerative colitis was confirmed by a doctor using specific tests.

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I am between 18 and 75 years old.

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My ulcerative colitis is active, with a moderate to severe score and extends beyond 15 cm from the anal verge.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is diagnosed as indeterminate colitis.

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My white blood cell count is high and I have had a fever over 38°C.

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I have been hospitalized for severe ulcerative colitis.

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I have not taken antibiotics in the last 30 days and do not expect to need any during the study.

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I have not had a fecal microbiota transplant in the last 3 months.

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I take more than 30 mg of prednisone daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Proportion of participants who achieve clinical response

Trial 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

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.

0 / 9Eligibility criteria met