R-3750 in Patients With 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of R-3750, a probiotic taken by mouth, and how well people can tolerate it. It is for adults ages 18–65 with mild to moderate ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine. The study will track symptoms and test blood and stool.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–65 years old and able to give written consent to join.
- Have UC confirmed by a colonoscopy (a camera exam of the colon) and tissue testing.
- Have mild to moderate UC, with a study disease score called MMDAI of 3–9.
- Take a steady dose of an aminosalicylate, a medicine for UC, with no changes for 4 weeks before joining. Do not plan to start other new medicines.
- Agree to use birth control if you or your partner could become pregnant. Men must not donate sperm during the study or for at least 30 days after dosing.
- For the added study group, have a camera exam of the lower colon unless results from an endoscopy done within 3 months before joining are available.
- Agree not to get any vaccines during the study.
Who can't join
- Be pregnant, planning pregnancy, or breastfeeding; or have severe UC with an MMDAI score of 10 or higher.
- Have a current or recent infection, including hepatitis B, hepatitis C, HIV, chronic chest or sinus infections, or COVID-19 within the past 3 months.
- Have used medicines that weaken the immune system, cancer drugs, or other treatment besides aminosalicylates within 3 months; or use steroids for UC, such as prednisone above 20 mg a day.
- Have used another study drug within 3 months, or longer if it stays in the body longer; probiotics within 1 week or during the trial; or antibiotics that treat many types of bacteria within 2 months.
- Have a major active disease other than UC in which the immune system attacks the body, a history of a severe allergic reaction or allergy to probiotics, or alcohol or drug abuse within 2 years.
- Have had a stroke, blood vessel disease in the brain needing treatment, or cancer. Exceptions are successfully treated basal cell skin cancer or very early cervical cancer treated more than 1 year before joining.
- Have certain heart signal problems or a serious irregular heartbeat, or major abnormal lab results, including liver enzyme levels above 1.5 times the normal upper limit.
- Have kidney, liver, blood, or other health problems, or any circumstance that the study doctor thinks could make the study unsafe or affect its results.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (5)
CA
- Amicis Research Center · Valencia, CA 91355Crystal Baltazar · Study contact · 818-639-8822 · cbaltazar@amicisresearch.comRobert Moghimi, MD · Principal investigatorMore trials in Valencia
FL
- AP Medical Research LLC · Miami, FL 33165Simon Gomez, BS · Study contact · 305-400-8899 · simon@apmedresearch.comIdania Fernandez, MD · Principal investigatorMore trials in Miami
- Edward Jenner Research Group, LLC · Plantation, FL 33317Rosario Beltran · Study contact · 954-676-7440 · r.beltran@edwardjmedicalresearch.comShadi Tarazi, MD · Principal investigatorMore trials in Plantation
- Adtremed Research Clinic · Tampa, FL 33634Yulio Aguila, CRC · Study contact · 813-999-1950 · yaguila@adtremed.comSuyet de la Morena-Perez, BS, CRC · Study contact · (813) 999-1950 · suyetperez@adtremed.comMoraima I Batista-Carmona, MD · Principal investigatorMore trials in Tampa
MN
- Mayo Clinic · Rochester, MN 55902Patricia Kammer · Study contact · 507-538-1827 · kammer.patricia@mayo.eduDarrel Pardi, MD · Principal investigatorMore trials in Rochester