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New treatment option for Ulcerative Colitis Chronic Mild
Official title R-3750 in Patients With Mild to Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT05666960
What this study is testing
What is R-3750?
R-3750 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis chronic mild.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal...
You likely can't join if
- 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...
- Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry
See the full eligibility 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)...
- 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, California, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, California, United States; Miami, Florida, United States; Plantation, Florida, United States; Tampa, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.