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

Conditions: This study aims to assess the bacterial flora in patients with healthy pouches and patients with have pouchitis. We aim to study the clinical and microbiological effectiveness of antibiotic and probiotic therapy in the modification of flora within these groups of patients.

Registration Number: EUCTR2007-007977-21-GB

Lead Sponsor: eeds Teaching Hospitals Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our primary research question is:<br><br>Do patients with pouchitis have different bacteria within the pouch when compared to people with healthy pouches? If so, what are the differences?<br>;Secondary Objective: Our secondary research question is: <br><br>Does giving antibiotics and VSL3 to patients with pouchitis improve their symptoms?Is there a subsequent change in the bacteria that are present within the pouch? If so, what are the changes and how do they correlate with symptom improvement?<br>;Primary end point(s): Inorder to satisfy the primary and secondary objectives of the study we shall employ the following outcome measures:<br><br>1. Evaluation of their quality of life using a validated and approved inflammatory bowel disease specific quality of life questionnaire (IBDQ – McMaster University)<br><br>2. Provision of faecal samples and subsequent microbiological culture and molecular testing to identify potential changes in bacterial diversity and species.

Secondary Outcome Measures