Trial · NCT06609447
The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
NCT06609447, Phase 4, Recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis. Trials, record NCT06609447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06609447
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis
- NCT number
- NCT06609447
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Ulcerative Colitis
- Interventions
- VSL#3, Placebo, Vedolizumab
- First posted
- 2024-09-24
- Last updated
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response rate at week 6 | At week 6 | The proportion of participants with a SCCAI score reduction of ≥3 points from baseline in the experimental group compared to the control group at week 6 |
| Secondary | Clinical Response rate at week 14 | At Week 14 | The proportion of participants in the experimental group compared to the control group at week 14 with: * A reduction in modified Mayo score of ≥30% and ≥3 points from baseline, along with a decrease of ≥1 point in the rectal bleeding subscore or a subscore of 0 or 1. * Or a PRO2 score showing at least a 50% reduction in rectal bleeding and stool frequency. * Or a reduction in SCCAI score of ≥3 points. |
| Secondary | Clinical Remission rate at week 14 | At Week 14 | The proportion of participants in the experimental group compared to the control group at week 14 with: * A modified Mayo score ≤2 points and no single item score \>1 point. * Or a PRO2 score with a rating of 0 for rectal bleeding and stool frequency. * Or a SCCAI score ≤2 points. |
| Secondary | Steroid-free Clinical Remission rate at week 14 | At Week 14 | The proportion of participants in the experimental group compared to the control group at week 14 with a modified Mayo score ≤2 points and no single item score \>1 point, and who have completely tapered off steroids. |
| Secondary | At week 2 on PRO2 and Urgency NRS through dairy daily | At Week 2 | At Week 2, assess the proportion of participants achieving a decrease in the PRO2 (Patient-Reported Outcome) scores for rectal bleeding and stool frequency, and the mean value of the Urgency Numeric Rating Scale (UNRS) for bowel movements. |
| Secondary | Inflammatory Bowel Disease Questionnaire (IBDQ) variation | At the end of treatment weeks 6 and 14 | The difference between the IBDQ scores obtained at Week 14 and Week 6, compared to the baseline (initial) IBDQ scores taken before the start of the intervention or treatment. |
| Secondary | The proportion of patients with a ≥50% decrease in fecal calprotectin (FC) and the changes in the Urgency Numeric Rating Scale (UNRS) | At the end of treatment weeks 6 and 14 | At Week 14 and Week 6, assess the proportion of participants achieving a decrease in fecal calprotectin (FC) levels of ≥50% from baseline, and the changes in the mean value of the Urgency Numeric Rating Scale (UNRS) from baseline. |
| Secondary | Adverse Events | Through Week 14 | Compare the incidence of adverse events between the experimental group and the control group at weeks 2, 6, and 14. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06609447
GET https://conductscience.org/api/trials/v1/NCT06609447/registered