E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Our primary research question is:
Do patients with pouchitis have different bacteria within the pouch when compared to people with healthy pouches? If so, what are the differences?
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E.2.2 | Secondary objectives of the trial |
Our secondary research question is:
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?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Inorder to satisfy the primary and secondary objectives of the study we shall employ the following outcome measures:
1. Evaluation of their quality of life using a validated and approved inflammatory bowel disease specific quality of life questionnaire (IBDQ – McMaster University)
2. Provision of faecal samples and subsequent microbiological culture and molecular testing to identify potential changes in bacterial diversity and species. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
patients will serve as their own control pre and post dosing of VSL3 |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The endpoint of the trial is defined as the completed recruitment, receipt of samples and final review of all patients identified to all arms of the study. The last consultation and review of safety data will occur at 4 months from their commencement in the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |