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Probiotic
Probiotic R-3750 for Ulcerative Colitis
Phase 1
Recruiting
Research Sponsored by Rise Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-65 years of age
Ability to provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and effect of an oral probiotic (R-3750) on mild to moderate ulcerative colitis patients, through patient-reported and physician-scored measures, blood, and fecal results.
Who is the study for?
Adults aged 18-65 with mild to moderate ulcerative colitis can join this trial. They must use birth control, avoid vaccinations during the study, and be able to consent. Those with recent drug abuse, probiotic use, chronic infections including COVID-19, major autoimmune diseases besides UC, high-dose steroid treatment for UC, severe allergies to probiotics or a history of stroke are excluded.
What is being tested?
The trial is testing the safety and effects of R-3750—a probiotic taken orally—on patients with ulcerative colitis. Participants will report their symptoms and undergo blood and stool tests to measure inflammation and how R-3750 affects fecal levels.
What are the potential side effects?
While specific side effects aren't listed for R-3750 in this summary, common side effects of probiotics may include digestive discomfort such as gas or bloating. Any unexpected reactions will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I agree to use effective birth control during and 30 days after the study.
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I will not get any vaccines during the study, including flu or COVID shots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To assess the tolerability of R-3750
Secondary study objectives
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Rise Therapeutics LLCLead Sponsor
4 Previous Clinical Trials
144 Total Patients Enrolled
Mayo ClinicOTHER
3,349 Previous Clinical Trials
3,061,060 Total Patients Enrolled
11 Trials studying Ulcerative Colitis
525 Patients Enrolled for Ulcerative Colitis
University of Colorado, DenverOTHER
1,808 Previous Clinical Trials
2,822,204 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
36 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chest infections, sinusitis, or COVID-19 in the last 3 months.I am between 18 and 65 years old.I agree to use effective birth control during and 30 days after the study.I will not get any vaccines during the study, including flu or COVID shots.I have not taken probiotics in the last 2 weeks.I am taking more than 20 mg/day of steroids for ulcerative colitis.I have had a stroke or another brain blood vessel condition that needs treatment.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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