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

Kangbuk Samsung Hospital

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: E. coli Nissle 1917 (Mutaflor®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04969679

MUTAUC01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

E. coli Nissle 1917 (Mutaflor®)

Active Comparator group

Description:

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

Treatment:

Drug: E. coli Nissle 1917 (Mutaflor®)

Placebo

Placebo Comparator group

Description:

Placebo group will receive placebo drug.

Treatment:

Drug: Placebo