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

NCT04969679 | Completed Phase 4

• 1 other identifier: MUTAUC01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Mutaflor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate the clinical remission between Mutaflor group and Placebo group

  4weeks, 8weeks

• Evaluate the clinical response between Mutaflor group and Placebo group

  4weeks, 8weeks

• Improvement in endoscopic scores between Mutaflor group and Placebo group

  8weeks

• Evaluate the endoscopic response between Mutaflor group and Placebo group

  8weeks

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

  8weeks

Study Arms (2)

E. coli Nissle 1917 (Mutaflor®)

ACTIVE COMPARATOR

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

Drug: E. coli Nissle 1917 (Mutaflor®)

Placebo

PLACEBO COMPARATOR

Placebo group will receive placebo drug.

Drug: Placebo

Interventions

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)

E. coli Nissle 1917 (Mutaflor®)

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)

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Soo-kyung Park

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36068716 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 21, 2021
• Study Start: March 16, 2018
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

KR (1)