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Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.

Ulcerative Colitis Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.

Clinical Trial Summary

E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.

Clinical Trial Description

This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC. Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04969679
Study type Interventional
Source Kangbuk Samsung Hospital
Contact
Status Completed
Phase Phase 4
Start date March 16, 2018
Completion date June 3, 2020
View Details
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