Recruiting NCT05666960
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: R-3750.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic, Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis
Overview
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.
Interventions
- Drug R-3750
Probiotic
Primary outcome measures
- To assess the tolerability of R-3750 [Time frame: 6 weeks]
Secondary outcome measures (1)
- Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [Time frame: 6 weeks]
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, 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 immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months
- Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry
- Use of steroidal drugs to treat UC (e.g., prednisone >20 mg/day)
- Use of probiotics within the last one (1) week and during the trial.
- Treatment with systemic broad-spectrum antibiotics in the past 2 months
- Major active systemic autoimmune disease other than UC
- History of anaphylaxis or allergies to probiotics
- History of alcohol or drug abuse within the past 2 years
- History of stroke, or any cerebrovascular disease requiring medication/treatment
- History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix >1 year prior to enrollment
- Significant laboratory abnormalities, including liver transaminases (AST or ALT) > 1.5X the upper limit of normal.
- Second degree or higher heart block or clinically significant arrythmia
- Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk
- Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Amicis Research Center — Valencia
- AP Medical Research LLC — Miami
- Edward Jenner Research Group, LLC — Plantation
- Adtremed Research Clinic — Tampa
- Mayo Clinic — Rochester
Identifiers
NCT: NCT05666960 · RISE R-3750-01