Actively Recruiting
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
Led by Rise Therapeutics LLC · Updated on 2026-01-29
36
Participants Needed
4
Research Sites
187 weeks
Total Duration
On this page
Sponsors
R
Rise Therapeutics LLC
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-65 years of age
- Able to provide written informed consent
- Confirmed diagnosis of ulcerative colitis by colonoscopy and histology with mild to moderate disease (MMDAI score 3-9)
- On a stable dose of aminosalicylate with no medication changes within 4 weeks before enrollment
- Women of childbearing potential and men with partners of childbearing potential agree to use birth control methods and men agree not to donate sperm during and for 30 days after dosing
- For expansion cohort, willing to undergo flexible sigmoidoscopy unless recent endoscopy within 3 months is available
- Agree to refrain from any vaccinations during the study period
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding
- Severe ulcerative colitis (MMDAI score ≥10)
- Active or recent infections including chronic infectious diseases like Hepatitis B, C, or HIV
- Recent chronic chest infections, bronchiectasis, sinusitis, or COVID-19 infection within past 3 months
- Treatment with immunosuppressants, anti-cancer drugs, or non-aminosalicylate therapies within last 3 months
- Received investigational drugs within 3 months before study entry
- Use of steroid drugs for ulcerative colitis with prednisone >20 mg/day
- Use of probiotics within 1 week before and during the trial
- Use of systemic broad-spectrum antibiotics in past 2 months
- Major active systemic autoimmune diseases other than ulcerative colitis
- History of anaphylaxis or allergies to probiotics
- History of alcohol or drug abuse within past 2 years
- History of stroke or cerebrovascular disease requiring treatment
- History of cancer except certain treated skin or cervical cancers more than 1 year prior
- Significant lab abnormalities including elevated liver enzymes (AST or ALT >1.5x upper limit)
- Second degree or higher heart block or significant arrhythmia
- Other significant medical conditions or lab abnormalities that may interfere with study or pose risk
- Any condition deemed by the investigator to compromise safety or data quality
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Amicis Research Center
Valencia, California, United States, 91355
Actively Recruiting
2
AP Medical Research LLC
Miami, Florida, United States, 33165
Actively Recruiting
3
Edward Jenner Research Group, LLC
Plantation, Florida, United States, 33317
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
Research Team
J
Janet Stephens, PhD
CONTACT
C
Christian Freguia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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