Testing a probiotic for mild to moderate ulcerative colitis
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
This study is testing a new probiotic to see if it can help people with mild to moderate ulcerative colitis feel better and improve their gut health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rise Therapeutics LLC Industry-sponsored |
| Drugs / interventions | upadacitinib, methotrexate, cyclophosphamide, prednisone |
| Locations | 4 sites (Valencia, California and 3 other locations) |
| Trial ID | NCT05666960 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of an oral probiotic called R-3750 in patients diagnosed with mild to moderate ulcerative colitis. Participants will take the probiotic and report their symptoms, while physicians will assess their condition using standardized measures. Additionally, blood and fecal samples will be collected to evaluate inflammation levels and the impact of the probiotic on gut health. The study is designed to gather both subjective and objective data on the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of mild to moderate ulcerative colitis.
Not a fit: Patients with severe ulcerative colitis or those not on a stable dose of aminosalicylate may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, safe option for managing symptoms of ulcerative colitis.
How similar studies have performed: Previous studies on probiotics for gastrointestinal conditions have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Valencia, California and 3 other locations
- Amicis Research Center — Valencia, California, United States (Recruiting)
- AP Medical Research LLC — Miami, Florida, United States (Recruiting)
- Edward Jenner Research Group, LLC — Plantation, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Janet Stephens, PhD
- Email: jstephens@risetherapeutics.com
- Phone: 6504178556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.