Ulcerative Colitis
Conditions
Keywords
Mutaflor
Brief 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.
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.
Interventions
DRUGE. 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)
DRUGPlacebo
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)
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group | 8weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical remission between Mutaflor group and Placebo group | 4weeks, 8weeks | 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. |
| Evaluate the clinical response between Mutaflor group and Placebo group | 4weeks, 8weeks | 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. |
| Improvement in endoscopic scores between Mutaflor group and Placebo group | 8weeks | 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. |
| Evaluate the endoscopic response between Mutaflor group and Placebo group | 8weeks | 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. |
| Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group | 8weeks | Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities. |
Countries
South Korea
Outcome results
None listed