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

Kangbuk Samsung Hospital134 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Ulcerative Colitis

Interventions

E. coli Nissle 1917 (Mutaflor®)DRUG

Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)

PlaceboDRUG

Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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 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 or biologics within 3months * history of using antibiotics or probiotics within 2 weeks * Pregnant or lactating woman * Requiring hospitalization and imminent need for surgery

Locations (1)

Soo-kyung Park

Seoul, South Korea

Outcomes

Primary Outcomes

Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group

The evaluation of the beneficial effects of Mutaflor on mild-to-moderate UC patients, was assessed by an increase in the IBDQ score more than 16 points from baseline to week 8. The Score can range from 32 to 224, with higher scores reflecting better HRQOL(Health-related quality of life)

Time frame: 8weeks

Secondary Outcomes

Evaluate the clinical remission between Mutaflor group and Placebo group

Partial Mayo≤1, assessed at week 4 or Mayo≤2, assessed at week 8. Mayo score can range from 0-12 with higher scores indicating worse severity.

Time frame: 4weeks, 8weeks

Evaluate the clinical response between Mutaflor group and Placebo group

Partial Mayo≤2 or decrease more than 2 points, assessed at week 4 or Mayo≤ 2 or decrease more than 2 points, assessed at week 8. Mayo score can range from 0-12 with higher scores indicating worse severity.

Time frame: 4weeks, 8weeks

Improvement in endoscopic scores between Mutaflor group and Placebo group

Assessed by the endoscopic subgroup score=0 of the mayo. Mayo Endoscopic Sub Scores can range from 0-3, with higher scores indicating worse severity.

Time frame: 8weeks

Evaluate the endoscopic response between Mutaflor group and Placebo group

Assessed by the endoscopic subgroup score=0 or decrease more than 1 point. Mayo Endoscopic Sub Scores can range from 0-3 with higher scores indicating worse severity.

Time frame: 8weeks

Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group

Data from ClinicalTrials.gov

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