A Phase 4 interventional study of E. coli Nissle 1917 (Mutaflor®) and Placebo in Ulcerative Colitis, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Kangbuk Samsung Hospital · Phase 4, Interventional, and 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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 134 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Active group will receive E. coli Nissle 1917 (Mutaflor®).
Drug: E. coli Nissle 1917 (Mutaflor®)
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)
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)
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
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
Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities.
Time frame: 8weeks
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Kangbuk Samsung Hospital