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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Probiotic
Amicis Research Center
Valencia, California, United States
RECRUITINGAP Medical Research LLC
Miami, Florida, United States
RECRUITINGEdward Jenner Research Group, LLC
Plantation, Florida, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGTo assess the tolerability of R-3750
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
Time frame: 6 weeks
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).
Time frame: 6 weeks
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