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R-3750 for Mild to Moderate Ulcerative Colitis

This study is testing a probiotic called R-3750 to see how safe and well-tolerated it is for people with mild to moderate ulcerative colitis (a chronic inflammatory bowel disease). Researchers want to see if R-3750 can help manage your symptoms. You may be able to join if you are between 18 and 65 years old, have been diagnosed with mild to moderate ulcerative colitis, and are currently on a stable dose of aminosalicylate medication. The main goal is to check the tolerability of R-3750 over 6 weeks. The study is currently recruiting about 36 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 36 participants.
What's involved
You will take an oral dose of R-3750. You will also provide patient-reported and physician-scored measures of your colitis, and have blood and fecal evaluations.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for tolerability is measured at 6 weeks.

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NCT05666960

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Rise Therapeutics LLC
~36 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:R-3750

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the tolerability of R-3750
Measured over 6 weeks

Conditions

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

Explore related trials

Ulcerative Colitis

Where it's being run

5 sites across 3 states
Florida3
California1
Minnesota1

Who to contact

Janet Stephens, PhD
[email protected]
6504178556
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To assess the tolerability of R-37506 weeks

    To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)