Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
Launched by KANGBUK SAMSUNG HOSPITAL · Jul 16, 2021
Trial Information
Current as of June 01, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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
About Kangbuk Samsung Hospital
Kangbuk Samsung Hospital is a leading healthcare institution in South Korea, renowned for its commitment to advanced medical research and clinical excellence. As a sponsor of clinical trials, the hospital integrates cutting-edge technology and innovative therapies to enhance patient care and outcomes. With a multidisciplinary team of experienced researchers and healthcare professionals, Kangbuk Samsung Hospital is dedicated to conducting rigorous clinical studies that adhere to the highest ethical standards. Its focus on translational medicine aims to bridge the gap between laboratory findings and clinical applications, ultimately contributing to the advancement of medical science and improving therapeutic options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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