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

Plain-language summary

This study examines the added benefit of the probiotic Mutaflor® (E. coli Nissle 1917), compared with a placebo, in ulcerative colitis patients who are on 5-ASA treatment. Patients over 19 with mild to moderate symptoms could take part. It was carried out as a Phase 4 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Kangbuk Samsung Hospital

Intervention

E. coli Nissle 1917 (Mutaflor®), Placebo

Start date

3/16/2018

Estimated completion

6/3/2020

Countries

South Korea

Related genes

Locations

• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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