Inflammatory bowel diseases
Conditions
Interventions
Group 1: Patients with Inflammatory Bowel Diseases and the indication for a biologic therapy and additional in vivo imaging: endoscopic ultrasound, performed at week 0, 2, 14, 52, 104
Group 2: Patient
Sponsors
UKSH Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Active inflammatory bowel disease - Indication for biological therapy (independent of recruitment for study) - written informed consent - stable dosage of corticosteroids (prednisone =20mg/day for at least 2 weeks or <20mg/day for at least 40 days) - stable dosages of immunomodulators (=1.5mg/kg/day or the highest tolerated dosage of azathioprine or =1 mg/kg/day or the highest tolerated dosage of 6-mercaptopurine with stable dosage for =1 month prior to baseline) for 1 month - stable dosage of rectal therapies with mesalamine or glucocorticoids is necessary at least two weeks before index examination.
Exclusion criteria
Exclusion criteria: - missing consent of the patient - known or suspected hypersensitivity to contrast agent fluorescein and/or butylscopolamin - gastrointestinal obstruction or suspected perforation - serious cardiovascular, renal or hepatic disease - impaired coagulation - elevated serum creatinine - acute diverticulitis - concomitant viral colitis i.e. cytomegalovirus infection - NSAID use and use of any medication that could potentially cause or aggravate colitis during the last four weeks prior initiation of biological therapy - toxic megacolon - abdominal abscess - increased risk of infectious complications (e.g. pyogenic infection <4weeks, enteric pathogens detected on stool analysis, active or latent tuberculosis, immunodeficiency, hepatitis B or C, live vaccination <4weeks), - pregnancy or lactation - malignant neoplasms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - perfusion of colonic wall at week 2 (measured by EUS, CLE, OCT oder O2C) | — |
Secondary
| Measure | Time frame |
|---|---|
| - total wall thickness, diameter of mucosal capillaries, permeability of colonic wall, mucosal oxygen saturation, endoscopic inflammation score of IBD, histological inflammation score, adaption of vascularity measured by time to peak intensity, the capillary diameter and crypt diameter (CLE) | — |
Countries
Germany
Contacts
Public ContactMark Ellrichmann
UKSH Kiel, Interdisziplinäre Endoskopie
Outcome results
None listed