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 Details — Status: Completed

Administrative data

• NCT number: NCT04969679
• Other study ID #: MUTAUC01
• Status: Completed
• Phase: Phase 4
• Start date: March 16, 2018
• Est. completion date: June 3, 2020

Study information

• Verified date: July 2021
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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
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)

Locations

Country	Name	City	State
Korea, Republic of	Soo-kyung Park	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 a- and ß-diversities.	8weeks