Mucosal biofilms in ulcerative colitis

Conditions: K51
Ulcerative colitis

Registration Number: DRKS00011090

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 25

Inclusion Criteria

Male or female, 18 years of age or older.
- Ability to provide informed consent.
- Patients with active ulcerative colitis (ddefined as Mayo score 3-9)

Exclusion Criteria

Patients who take antibiotics or took antibiotics in the previous 3 months
Patients who take or took (in the previous 3 months) an immunomodulating agent other than 5-ASA or steroids as e.g. thiopurines, TNF-a antibodies
Previous or current colonic neoplasia
Unwillingness to participate
Pregnancy or nursing women
Patients after total or subtotal colectomy
Severe concomitant disease

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint of the study is the longitudinal (baseline, after 2 months, after 6 months to 1 year) comparative microbial analysis of mucosal biofilms, mucosal biopsy samples and stool samples from ulcerative colitis patients based on 16S rDNA sequencing.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the effect of treatment (e.g. 5-ASA) or disease activity on bacterial composition (baseline, after 2 months, after 6 months to 1 year). Furthermore, based on 16S rDNA data, specific FISH-probe sets will be developed to quantitatively analyze bacterial abundance (in a ratio to a general bacterial probe) and spatial distribution, with the use of confocal fluorescnece microscopy and subsequent image analysis (time points are the same as mentioned above).