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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
E. coli Nissle 1917 (Mutaflor®)
Placebo
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Mutaflor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soo-kyung Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

E. coli Nissle 1917 (Mutaflor®)

Placebo

Arm Description

Active group will receive E. coli Nissle 1917 (Mutaflor®).

Placebo group will receive placebo drug.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 7, 2021
Last Updated
July 16, 2021
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04969679
Brief Title
Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Mutaflor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E. coli Nissle 1917 (Mutaflor®)
Arm Type
Active Comparator
Arm Description
Active group will receive E. coli Nissle 1917 (Mutaflor®).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group will receive placebo drug.
Intervention Type
Drug
Intervention Name(s)
E. coli Nissle 1917 (Mutaflor®)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
Description
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
Secondary Outcome Measure Information:
Title
Evaluate the clinical remission between Mutaflor group and Placebo group
Description
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
Title
Evaluate the clinical response between Mutaflor group and Placebo group
Description
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
Title
Improvement in endoscopic scores between Mutaflor group and Placebo group
Description
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
Title
Evaluate the endoscopic response between Mutaflor group and Placebo group
Description
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
Title
Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group
Description
Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities.
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Soo-kyung Park
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36068716
Citation
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.
Results Reference
derived

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

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