ASSESSMENT OF THE ROLE OF THE PROBIOTIC VSL3® IN THE TREATMENT OF POUCHITIS AFTER ILEAL POUCH-ANAL ANASTOMOSIS - VSL3

eeds Teaching Hospitals Trust0 个研究点目标入组 20 人开始时间: 2010年12月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•All IPAA patients who have had a pouch procedure performed for inflammatory bowel disease and either have normal pouch function, pouch dysfunction or acute or chronic relapsing pouchitis, and are capable of giving written informed consent will be invited into the study. Consent will be obtained prior to any faecal sampling or biopsy collection.
•Patients with active pouchitis must fulfil the Pouch Disease Activity Index (PDAI) criteria (See Appendix 1), which consists of a cumulative score based upon a triad including sub-scoring of clinical symptoms, endoscopic and histological evidence of inflammation. The biopsy must therefore be obtained when the faecal sample is collected.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion Criteria
•Patients unable or declining to provide informed consent
•Patients who provide samples with inadequate stool and tissue to analyse
•Patients who are on antimicrobials, probiotics or immunosuppressant therapy e.g. steroids.
•Patients who develop any adverse reaction to VSL#3® therapy.
•Patients who have a known sensitivity or allergy to the antibiotic ciprofloxacin.
•Patients unfit or unwilling to receive sedation / general anaesthesia
•Patients who are pregnant, breast feeding, or planning for pregnancy within four months of recruitment into the study.

发起方

eeds Teaching Hospitals Trust