K51
Conditions
Interventions
Group 1: Patients with diagnosis ulcerative colitis.
For the examination weeks 0, 6, 14 and 22 abdominal ultrasound is measured as well as stool and blood markers and medicament levels.
Sponsors
Internistische Gemeinschaftspraxis
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Reliable diagnosis of ulcerative colitis> 3 months (endoscopically and clinically) 2. Secured disease due to increased fecal calprotectin = 100 µg / g and / or endoscopic score UCEIS = 3, within 3 weeks prior to baseline 3. Ultrasound detectable disease; Sonographic signs of active inflammation, determined by the thickness of the intestinal wall:> 3 mm (colon) 4. If treatment with vedolizumab independent of the present study has been performed in accordance with routine medical practice, there should be at least a 12 week break between end and beginning 5. Age between = 18 and 80 years 6. Signed written consent is available
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. Indication for vedolizumab therapy outside the product information 3. Contraindications for treatment with vedolizumab (according to product information) 4. ileostomy or ileoanal pouch 5. Infectious colitis (e.g., Clostridium difficile colitis, cytomegalovirus colitis) 6. Obesity = Grade I (BMI> 30): inadequate sonographic log wall imaging 7. Proctitis 8. Participation in an intervention study within the last 30 days prior to initiation of therapy. 9. Other medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The goal is to predict the clinical response to vedolizumab therapy at week 14 by at least two improved markers (drug levels, abdominal ultrasound and / or calprotectin) at week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measuring of fecal calprotectin, abdominal ultrasound, and drug level at week 6 to predict the likelihood of clinical response to the integrin antibody vedolizumab therapie at week 22. In addition, it is being investigated whether other stool markers (lactoferrin, S100A12 or PMN elastase) can be used as predictors of clinical response to vedolizumab therapy. | — |
Countries
Germany
Contacts
Public ContactUlf Helwig
Universität zu Kiel und Internistische Gemeinschaftspraxis
Outcome results
None listed