Testing a probiotic for mild to moderate ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Adtremed Research Clinic
  Tampa, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Janet Stephens, PhD
• Email: jstephens@risetherapeutics.com
• Phone: 6504178556

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Novel therapeutics for acute ulcerative colitis

  This trial tests an oral (and sometimes IV) drug called BRS201 in adults with severe ulcerative colitis who have not improved with standard treatments.

  Recruiting Phase 2 Brigham and Women's Hospital · Chestnut Hill, Massachusetts and 1 other locations · NCT06420492

• Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

  This study is testing if a medication called mirikizumab can help children with ulcerative colitis or Crohn's disease feel better over a long period of time.

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• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

  This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.

  Recruiting at 5 sites Austin Health · Hobart and 6 other locations · NCT07916727

• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

  Recruiting Catholic University of the Sacred Heart · Roma, RM · NCT07724990

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

• Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

  This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619547

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.