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NCT Number: NCT04969679

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soo-kyung Park

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group

    Time frame: 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 outcomes

  1. Evaluate the clinical remission between Mutaflor group and Placebo group

    Time frame: 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.

  2. Evaluate the clinical response between Mutaflor group and Placebo group

    Time frame: 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.

  3. Improvement in endoscopic scores between Mutaflor group and Placebo group

    Time frame: 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.

  4. Evaluate the endoscopic response between Mutaflor group and Placebo group

    Time frame: 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.

  5. Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group

    Time frame: 8weeks

    Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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