Compositional changes in gut microbiota following induction therapy in patients with active ulcerative colitis

Completed

Conditions: ulcerative colitis and inflammatory bowel disease
10017969

Registration Number: NL-OMON45052

Lead Sponsor: Maag-darm-leverziekten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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
Pregnancy/lactation
Obesity (defined as a body mass index > 30 kg/m2)
Medical treatment for diabetes mellitus
Serious comorbidities (precluding participation in the study in the opinion of the treating physician)
Use of rectal or systemic steroid therapy, biological agents or methotrexate during the last 2 months before participation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Microbial composition of both FAM and MAM using a phylogenetic microarray<br /><br>(Human Intestinal Tract (HIT) Chip) and next generation sequencing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical disease activity indices<br /><br>Biochemical parameters (faecal calprotectin level, C-reactive protein level,<br /><br>full blood count, albumin level)</p><br>