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

• Status: Completed
• Trial end date: 2020-06-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kangbuk Samsung Hospital

Criteria

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