R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Phase 1

Recruiting

• Conditions: Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic; Ulcerative Colitis

• Registration Number: NCT05666960
• Lead Sponsor: Rise Therapeutics LLC

Brief Summary

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis.

Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2022-12-28
• Study Start: 2023-02-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the tolerability of R-3750	6 weeks	To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)

Secondary Outcome Measures

Name	Time	Method
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores	6 weeks	To assess the number of participants that show improvements in the ulcerative colitis disease severity by collecting IBDQ. The scores are based on a numbering system from one (1) to seven (7) where seven (7) is the least about of trouble with your bowels and one (1) is the most. The numbers are totaled to provide a total score from 32 to 224. Where 32 is a better outcome and 224 is a worse outcome. This is compared from the beginning and again at different times to see if there are any changes to your microbiome before and after taking R-3750 (probiotic).

Trial Locations

Locations (3)

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

AP Medical Research LLC; 🇺🇸 Miami, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States