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

Phase

Condition

Colic

Crohn's Disease

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT04969679

MUTAUC01

Ages > 19
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
Patient who signed the consent form

Exclusion

Exclusion Criteria:

The extent of ulcerative colitis is limited to proctitis
History of bowel resection
History of using other medication than 5-ASA such as immunomodulators, steroid orbiologics within 3months
history of using antibiotics or probiotics within 2 weeks
Pregnant or lactating woman
Requiring hospitalization and imminent need for surgery

Study Design

March 16, 2018

June 03, 2020

Study 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.

Connect with a study center

Soo-kyung Park
Seoul,
Korea, Republic of
Site Not Available

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