NL-OMON45052
Completed
Not Applicable
Compositional changes in gut microbiota following induction therapy in patients with active ulcerative colitis - Changes in gut microbiota following induction therapy in active UC
Maag-darm-leverziekten0 sites16 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ulcerative colitis and inflammatory bowel disease
- Sponsor
- Maag-darm-leverziekten
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 18 \- 60 years
- •established diagnosis of ulcerative colitis (confirmed by clinical, endoscopic and histological features)
- •moderate or severe disease activity (defined as a Mayo score \>6 for patients with UC)
- •indication for endoscopy (according to the Dutch CBO guidelines for diagnosis and treatment of IBD in adults)
- •indication for induction therapy with oral prednisone (according to the Dutch CBO guidelines for diagnosis and treatment of IBD in adults)
- •disease activity confirmed by endoscopy with at least ulcerative lesions present at baseline (ileo)colonoscopy
- •signed informed consent
Exclusion Criteria
- •Concomitant gastrointestinal disorder
- •Previous surgery for IBD
- •Severe disease possibly requiring surgical treatment
- •Isolated proctitis
- •Systemic antibiotic, antiviral, or antifungal treatment during the last 2 months before participation
- •Use of probiotics during the last 3 weeks before participation
- •Use of antidiarrheal medications during the last week before participation
- •Parenteral nutrition, vegetarianism, veganism, use of dietary supplements
- •Alcohol misuse in the last year before participation (more than 3\-4 units or 2\-3 units per day for men and women respectively)
- •Drug misuse in the last year before participation
Outcomes
Primary Outcomes
Not specified
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