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BRS201 for Ulcerative Colitis (TURTLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a confirmed diagnosis of UC for > 3 months
Be older than 18 years old
Must not have
Crohn's Disease or Indeterminate colitis
Chronic kidney disease as defined by GFR <60mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is testing a new drug called BRS201 to see if it can help patients with mild ulcerative colitis. Participants will take the drug and a placebo for 4 weeks each in a

Who is the study for?
This trial is for people with active mild ulcerative colitis. Participants will be involved in the study for 12 weeks and must attend 7 visits at the study site. They'll take an oral medication twice daily, keep a log of their medication intake, and provide blood, stool, and urine samples.
What is being tested?
The efficacy of BRS201 is being tested against a placebo in treating ulcerative colitis. It's a crossover study where participants switch between the drug and placebo every four weeks to compare effects.
What are the potential side effects?
Possible side effects are not specified here but generally could include gastrointestinal discomfort, allergic reactions or other symptoms related to immune response due to the nature of treatment involving inflammatory bowel disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ulcerative colitis for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Crohn's Disease or my condition is similar but not specifically diagnosed.
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My kidney function is reduced with a GFR under 60 mL/min.
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I have a weakened immune system from birth or developed over time.
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I was diagnosed with cancer within the last 5 years.
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My blood pressure is usually higher than 140/90 and not well-controlled.
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I have diabetes or systemic lupus.
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My liver is not working properly.
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I am currently using rectal treatments.
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I am likely to have surgery to remove part or all of my colon soon.
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I have colitis caused by an infection or medication.
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I have a history or risk of heart conditions like arrhythmia or heart failure.
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I haven't taken certain medications like Vitamin C, steroids, or immune modulators in the last six weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Normalization of fecal calprotectin lab measurements
Secondary outcome measures
Change in fecal calprotectin lab measurements
Measurement of sulfur metabolites in urine
Partial Mayo score
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: BRS201 ArmActive Control1 Intervention
In Group 1 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 3 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
Group II: Placebo Comparator: Placebo ArmPlacebo Group1 Intervention
In Group 1 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation. In Group 3 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,628 Previous Clinical Trials
11,474,622 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
181 Patients Enrolled for Ulcerative Colitis
~12 spots leftby Aug 2025
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