Evaluation of therapeutic response of chronic inflammatory bowel diseases by deep morphological phenotyping

Conditions: Inflammatory bowel diseases

Registration Number: DRKS00031624

Lead Sponsor: KSH Kiel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 400

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

-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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- perfusion of colonic wall at week 2 (measured by EUS, CLE, OCT oder O2C)

Secondary Outcome Measures

Name	Time	Method
- 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)