Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis - TURN trial

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•*Ability to give informed consent
•*Established left sided ulcerative colitis according to the Lennard-Jones criteria
•*SCCAI (Simple Clinical Colitis Activity Index) of 4 - 11
•*Endoscopic Mayo score of >1
•*Stable dose of thiopurines, 5-ASA, or corticosteroids in preceding 8 weeks
•*Women need to use reliable contraceptives during participation in the study

•* condition leading to profound immunosuppression
•o For example: HIV, infectious diseases leading to imunosuppression, bone marrow malignancies
•o Use of systemic chemotherapy
•* Anti-TNF treatment in preceding 2 months
•* Ciclosporine treatment in preceding 4 weeks
•* Prednisolone dose * 10 mg
•* Life expectancy < 12 months
•* Use of antibiotics in preceding 6 weeks
•* Use of probiotic treatment in preceding 6 weeks
•* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
•* History of surgery:
•o hemicolectomie (defined as: surgery resulting in a resection of > * of the colon)
•o presence of a pouch due to surgery
•o Presence of stoma
•* Known intra-abdominal fistula
•* Pregnancy or women who give brestfeeding
•* Vasopressive medication, icu stay
•* Signs of ileus, diminished passage
•* Allergy to macrogol or substituents, eg peanuts, shellfish

发起方