R-3750 in Patients With Mild to Moderate Ulcerative Colitis (NCT05666960) | Clinical Trial Compass
RecruitingPhase 1
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
United States36 participantsStarted 2023-02-27
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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INCLUSION CRITERIA:
* 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
* For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)
* For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available
* Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)
EXCLUSION CRITERIA:
* 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
* Treatment with immunosupp…