PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis — PROREM UC  

Ulcerative Colitis Clinical Trial

Official title: A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC

Status Terminated

Clinical Trial 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.

Clinical Trial Description

This is a Phase II a, parallel-groups, randomized, double-blind, placebo-controlled, single-center, dose finding study in subjects with UC in remission. Two different oral doses of VSL#3® added to standard therapy (5-ASA) will be investigated compared to standard therapy (5-ASA) plus placebo (in a 1:1:1 ratio).

All patients will receive standard therapy for maintaining remission. 39 subjects will be randomly assigned to 1 of the 3 treatment arms for the 12-month treatment period as following:

• group A: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets per day for 12 months (900 billion of bacteria per day)

• group B: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets twice a day (1800 billion of bacteria per day) for 12 months

• group C: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus placebo for 12 months.

Subject participation in this study will be approximately 20 months which includes up to a 8-week screening period, a 12-month treatment period, and a 6-month follow-up period. At the conclusion of the 12-month treatment period, subjects will continue in the 6-month follow-up period (telephone contact conducted after 6 months). ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT03415711
• Study type: Interventional
• Source: VSL Pharmaceuticals
• Status: Terminated
• Phase: N/A
• Start date: April 28, 2017
• Completion date: April 24, 2019