Evaluation of therapeutic response of chronic inflammatory bowel diseases by deep morphological phenotyping - „PicIBD (Picture IBD)

KSH Kiel0 个研究点目标入组 400 人开始时间: 2024年2月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•-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

发起方

KSH Kiel