R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Part of paid clinical trials in Valencia, California.

Sponsor
Rise Therapeutics LLC
Study ID
NCT05666960
Phase
PHASE1
Status
Recruiting

Conditions

  • Ulcerative Colitis
  • Ulcerative Colitis Chronic
  • Ulcerative Colitis Chronic Mild
  • Ulcerative Colitis Chronic Moderate

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • R-3750 — DRUG
    Probiotic

Study Details

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.

Key Dates

Start date
Feb 27, 2023
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To assess the tolerability of R-3750 [ Time Frame: 6 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Amicis Research CenterValenciaCalifornia91355
Crystal Baltazar
818-639-8822
Robert Moghimi, MD (PRINCIPAL_INVESTIGATOR)
AP Medical Research LLCMiamiFlorida33165
Simon Gomez, BS
305-400-8899
Idania Fernandez, MD (PRINCIPAL_INVESTIGATOR)
Edward Jenner Research Group, LLCPlantationFlorida33317
Rosario Beltran
954-676-7440
Shadi Tarazi, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55902
Patricia Kammer
507-538-1827
Darrel Pardi, MD (PRINCIPAL_INVESTIGATOR)

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