Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: E. coli Nissle 1917 (Mutaflor®)Drug: Placebo
- Registration Number
- NCT04969679
- Lead Sponsor
- Kangbuk Samsung Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E. coli Nissle 1917 (Mutaflor®) E. coli Nissle 1917 (Mutaflor®) Active group will receive E. coli Nissle 1917 (Mutaflor®). Placebo Placebo Placebo group will receive placebo drug.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.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.
Trial Locations
- Locations (1)
Soo-kyung Park
🇰🇷Seoul, Korea, Republic of