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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E. coli Nissle 1917 (Mutaflor®) | Active Comparator | Active group will receive E. coli Nissle 1917 (Mutaflor®). |
|
| Placebo | Placebo Comparator | Placebo group will receive placebo drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soo-kyung Park | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36068716 | Derived | 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. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | 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) |
|
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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |