NCT05666960 R-3750 in Patients With Mild to Moderate Ulcerative Colitis
| NCT ID | NCT05666960 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rise Therapeutics LLC |
| Condition | Ulcerative Colitis Chronic Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-02-27 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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,
Frequently Asked Questions
Who can join the NCT05666960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ulcerative Colitis Chronic Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05666960 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05666960 currently recruiting?
Yes, NCT05666960 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rise Therapeutics LLC to inquire about joining.
Where is the NCT05666960 trial being conducted?
This trial is being conducted at Valencia, United States, Miami, United States, Plantation, United States, Rochester, United States.
Who is sponsoring the NCT05666960 clinical trial?
NCT05666960 is sponsored by Rise Therapeutics LLC. The trial plans to enroll 36 participants.
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