Combining Probiotic VSL#3 with Vedolizumab for 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 clinical trial investigates the efficacy and safety of using the probiotic VSL#3 in conjunction with the biologic Vedolizumab for treating moderate ulcerative colitis. Patients aged 18-85 with moderate active UC are randomly assigned to receive either the probiotic or a placebo alongside Vedolizumab over a 14-week period. The primary outcomes focus on clinical improvement as measured by the SCCAI score and fecal calprotectin levels. Secondary outcomes include overall clinical response, remission rates, and quality of life assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject must be a man or woman aged 18-85 years, inclusive.
* 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.
* Subject has moderate active UC and had a Mayo score of 6-10 at screening.
* Planned treatment with Vedolizumab as initial therapy or reinduction, with reinduction defined as no vedolizumab treatment within 1 year.
* 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:

  1. 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.
  2. 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.
* No increase in dose of oral 5-ASA and Immunosuppressants could be allowed if it is maintained stable at least 2 weeks before screening.
* Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
* Willing and able to complete the required Subject Diary.
* Willing and able to meet all study requirements, including attending all assessment visits and phone calls.

Exclusion criteria:

* Diagnosis of Crohn's disease, undetermined IBD or other colitis.
* UC disease limited to the rectum (\<15 cm from the anal verge)
* Steroid therapy initiation within 2 weeks before screening visit.
* Used antibiotics for intestinal or other infections within 2 weeks of the screening
* Use of other probiotics preparations within the last 2 weeks before study entry (screening)
* Used rectal 5-ASA within the past week before study entry (screening)
* Adjustment of oral 5-ASA and immunosuppressant dosages due to disease progression after colonoscopy screening until enrollment.
* Within 1 week prior to screening, the participant has taken nonsteroidal anti-inflammatory drugs (NSAIDs) or anti-diarrheal medications for 5 consecutive days.
* Positive Clostridioides difficile detection toxin results within the past month prior to screening.
* Pregnancy and breastfeeding women
* Other biologics/advanced therapies are used as concomitant therapy and Previous use of other biologics
* History of allergy to maltose and/or cornstarch and/or silica
* Subjects with severe primary heart, liver, lung, kidney, hematologic, or serious diseases that affect their survival, such as cancer, AIDS, asthma, kidney stones, renal dysfunction; urine protein \>+, 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.

Where it's running

• Chongqing General Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Zhejiang Provincial Hospital of Traditional Chinese Medicine
  Hangzhou, Zhejiang, China Recruiting
• The Seventh Medical Center, PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting
• The Second Affiliated Hospital of Xi'an Jiaotong University
  Xi’an, Shanxi, China Not yet recruiting

Study contacts

• Study coordinator: Yan Chen, PhD
• Email: chenyan72_72@zju.edu.cn

Similar studies

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

• Comparing subcutaneous and intravenous vedolizumab for inflammatory bowel disease with remote monitoring

  This study is testing if a digital health system can help people with inflammatory bowel disease stick to their vedolizumab treatment, whether they receive it through an injection under the skin or through an IV, and how it affects their health over 22 weeks.

  Recruiting at 2 sites Mercy Medical Center · New Orleans, Louisiana and 5 other locations · NCT06750731

• Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

  This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

  Recruiting at 78 sites Phase 4 Takeda · Birmingham, Alabama and 100 other locations · NCT06581328

• Long-term vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

  This extension tests whether continuing subcutaneous vedolizumab is safe and helps children and teenagers with moderate to severe ulcerative colitis or Crohn's disease stay well.

  Recruiting at 12 sites Phase 3 Takeda · Phoenix, Arizona and 46 other locations · NCT06405087

• Vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

  This study is testing how well the drug vedolizumab works for children and teenagers with ulcerative colitis or Crohn's disease when given through injections after an initial dose through an IV.

  Recruiting at 26 sites Phase 3 Takeda · Phoenix, Arizona and 53 other locations · NCT06100289

• Vedolizumab effects on gut microbes and symptom improvement in ulcerative colitis

  This study will test whether vedolizumab changes gut microbes and metabolites and helps adults with moderate to severe ulcerative colitis.

  Recruiting Phase 4 Second Affiliated Hospital, Zhejiang University, School of Medicine · Zhengzhou, Hangzhou · NCT05481619

• Vedolizumab treatment for children with ulcerative colitis or Crohn's disease

  This study is testing how safe the medication vedolizumab is for children with ulcerative colitis or Crohn's disease who have already tried it before.

  Recruiting at 44 sites Phase 3 Takeda · Mobile, Alabama and 97 other locations · NCT05442567

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.