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.
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
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
Single group
R-3750
DrugProbiotic
To assess the tolerability of R-3750
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
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).
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