K51
Conditions
Interventions
Group 1: Colitis ulcerosa patients will receive standard of care treatment during the study e.g. intake of 5-ASA or steroids, but not of other immunomodulating agents such as thiopurines or TNF-alpha
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Austria
Contacts
Public ContactChristoph Gasche
Medizinische Universität Wien
Outcome results
None listed