Boosting Biologics in UC
NCT04241029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2024-05-06
Summary
This study evaluates the safety of the probiotic compound IDOFORM TRAVEL® in patients with ulcerative colitis undergoing anti-TNF treatment with insufficient clinical response. Furthermore, the study aims to explore the composition of the bacteria of the gut as well as the immunological activity in patients with ulcerative colitis undergoing anti-TNF treatment, aiming to identify differences between groups of patients responding and not responding adequately to treatment.
The project will explore whether probiotics have beneficial effects as adjuvant therapy in ulcerative colitis patients with insufficient response to anti-TNF treatment.
Conditions
- Ulcerative Colitis
- Inflammatory Bowel Diseases
Interventions
- DIETARY_SUPPLEMENT
-
IDOFORM®Travel
Four capsules IDOFORM®Travel orally every 24 hour (12\*10\^9 cfu/day) for eight weeks.
Sponsors & Collaborators
-
Helse Sor-Ost
collaborator OTHER_GOV -
Oslo University Hospital
lead OTHER
Principal Investigators
-
Asle Medhus, MD, PhD · Oslo University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-25
- Primary Completion
- 2023-12-15
- Completion
- 2023-12-15
Countries
- Norway
Study Locations
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