Ulcerative Colitis
Conditions
Interventions
Experimental Arms:Treatment with probiotic VSL#3 combined with vedolizumab
Subjects will receive two sachets daily of VSL#3 for 14 weeks. Vedolizumab will be administere as per clinical practice with the following schedule: 300 mg ev at 0, 2 and 6, 14 weeks
Control Arms:Treatment with placebo combined with vedolizumab
Subjects will receive two sachets daily of Placebo for 14 weeks. Vedolizumab will be administere as per clinical practice with the following schedule: 300 mg ev at 0, 2 and 6, 14 weeks
Sponsors
2nd Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Subject must be a man or woman aged 18-85 years, inclusive. 2.Diagnosed with ulcerative colitis (UC) at least 90 days prior to baseline, supported by comprehensive colonoscopy findings and histopathological evidence obtained within the past year. Participants must provide full colonoscopy or sigmoidoscopy reports along with pathology results conducted within the last 3 months, as well as blood indicators (within 1 week) at baseline screening. Individuals currently experiencing infection, dysplasia, or malignancy will be excluded from participation. 3. Subject has moderate active UC and had a Mayo score of 6-10 at screening 4.Planned treatment with Vedolizumab as initial therapy or reinduction, with reinduction defined as no vedolizumab treatment within 1 year 5.Confirmed by the investigator that despite receiving at least one of the following treatments, the subject has shown an inadequate response, loss of response, or intolerance: a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide), where the subject exhibits ongoing signs and symptoms of active disease during at least 4 weeks of treatment with mesalamine 2.4 g/day, sulfasalazine 4 g/day, olsalazine 1 g/day, or balsalazide 6.75 g/day. b. Immunosuppressants: failure to respond after receiving at least 42 consecutive days of treatment with azathioprine, 6-mercaptopurine, or methotrexate (MTX) injections prior to baseline (Week 0), with minimum doses of azathioprine = 0.75 mg/kg/day or 6-MP = 0.5 mg/kg/day (rounded to the nearest tablet dose) or MTX = 15 mg/week (SC/IM), or the highest tolerated dose due to adverse effects such as leukopenia, elevated liver enzymes, or nausea. 6. No increase in dose of oral 5-ASA and Immunosuppressants could be allowed if it is maintained stable at least 2 weeks before screening 7. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 8. Willing and able to complete the required Subject Diary. 9. Willing and able to meet all study requirements, including attending all assessment visits and phone calls.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Crohn‘s disease, undetermined IBD or other colitis. 2. UC disease limited to the rectum (+, microscopic hematuria, ALT >2N (N is the upper limit of normal), Cr > normal upper limit, platelet count <50x10^9/L, white blood cell count <3.0x10^9/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response rate at week 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response rate at week 14;Clinical Remission rate at week 14;Steroid-free Clinical Remission rate at week 14; At week 2 on PRO2 and Urgency NRS through dairy daily;Inflammatory Bowel Disease Questionnaire (IBDQ) variation;The proportion of patients with a =50% decrease in fecal calprotectin (FC) and the changes in the Urgency Numeric Rating Scale (UNRS); | — |
Countries
China
Contacts
Public ContactChenyan
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Outcome results
None listed