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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2020-06-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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E. coli Nissle 1917 (Mutaflor®)

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

Group Type ACTIVE_COMPARATOR

E. coli Nissle 1917 (Mutaflor®)

Intervention Type 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

Placebo group will receive placebo drug.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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)

Interventions

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E. coli Nissle 1917 (Mutaflor®)

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

Placebo

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

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No