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Tests treatment safety and results for Ulcerative Colitis
Official title The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT06609447
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ulcerative colitis.
Also referred to as Vedolizumab 300 mg Injection.
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
- An imbalance in the gut microbiota and mucosal immune dysfunction leading to intestinal inflammation are central to the pathogenesis of ulcerative colitis (UC). Both international and domestic inflammatory bowel disease (IBD) guidelines consistently recommend the use of the probiotic VSL#3 for inducing or maintaining remission in cases of mild-to-moderate UC.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 85
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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)
See the full eligibility 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...
- 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:
- 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...
- 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...
- 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.
- 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
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Huzhou, Zhejiang, China
- Jinhua, Zhejiang, China
- Quzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Xi’an, Shanxi, China; Chengdu, Sichuan, China and 5 more location(s). 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.