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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: E. coli Nissle 1917 (Mutaflor®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E. coli Nissle 1917 (Mutaflor®)<br>Active group will receive E. coli Nissle 1917 (Mutaflor®). | Drug: E. coli Nissle 1917 (Mutaflor®)<br>* 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)<br>|
| Placebo Comparator: Placebo<br>Placebo group will receive placebo drug. | Drug: Placebo<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mutaflor