About this trial

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 criteria

Qualifiers

18-65 years of age

Ability to provide written informed consent

Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9

On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug

Disqualifiers

Pregnancy, planned pregnancy, breastfeeding women

Evidence of severe UC disease (MMDAI score greater than or equal to 10)

Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV

Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months

Trial design

Treatments tested in this trial

  • R-3750

Treatment groups

No treatment groups listed

Locations

5
Amicis Research Center91355, ValenciaCalifornia, United States
AP Medical Research LLC33165, MiamiFlorida, United States
Edward Jenner Research Group, LLC33317, PlantationFlorida, United States
Adtremed Research Clinic33634, TampaFlorida, United States

Sponsors and collaborators

Rise Therapeutics LLC

Lead sponsor

Mayo Clinic

Collaborator

University of Colorado, Denver

Collaborator