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

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.

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: E. coli Nissle 1917 (Mutaflor®); Drug: Placebo

Detailed 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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Soo-kyung Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E. coli Nissle 1917 (Mutaflor®); Active group will receive E. coli Nissle 1917 (Mutaflor®).	Drug: E. coli Nissle 1917 (Mutaflor®); 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)
Placebo Comparator: Placebo; Placebo group will receive placebo drug.	Drug: Placebo; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	8weeks
Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group	Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities.	8weeks

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• Park SK, Kang SB, Kim S, Kim TO, Cha JM, Im JP, Choi CH, Kim ES, Seo GS, Eun CS, Han DS, Park DI. Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis. Korean J Intern Med. 2022 Sep;37(5):949-957. doi: 10.3904/kjim.2021.458. Epub 2022 Mar 31.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): June 3, 2020

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Mutaflor
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: MUTAUC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No