drugset / Trial / NCT03415711
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
RandomizedParallel-groupDouble-blindSupportive care
Summary
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated. The aim of this study is to evaluate the long-term efficacy of two different doses of VSL#3® added on standard therapy (5-ASA) in maintaining remission in an adult population of patients with UC, compared with the standard therapy (5-ASA) plus placebo. The investigators hypothesized that adding VSL#3® to mesalamine would lead to higher remission rate at long-term evaluation.
Timeline
- Start
- 2017-04-28
- Primary completion
- 2019-04-24
- Completion
- 2019-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Mesalamine | Small molecule | 2.4 g | — |