RecruitingPhase 1NCT05666960

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis


Sponsor

Rise Therapeutics LLC

Enrollment

36 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called R-3750 for people with mild to moderate ulcerative colitis (UC), a condition that causes inflammation and sores in the large intestine. Researchers want to see if this treatment is safe and effective when added to standard UC medication. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with mild to moderate UC confirmed by colonoscopy - You are on a stable dose of aminosalicylate medication (no changes in the past 4 weeks) - You are willing to use birth control during the study (if applicable) **You may NOT be eligible if...** - You are pregnant, planning to become pregnant, or breastfeeding - You have severe UC - You have an active infection such as Hepatitis B, C, or HIV - You have taken immunosuppressant drugs or steroids for UC in the last 3 months - You have taken antibiotics in the past 2 months - You have a history of cancer (with some exceptions), stroke, or serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-3750

Probiotic


Locations(4)

Amicis Research Center

Valencia, California, United States

AP Medical Research LLC

Miami, Florida, United States

Edward Jenner Research Group, LLC

Plantation, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05666960


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