Probiotic and Crohn’s Disease Study

Probiotics are a food supplement containing living microorganisms, which upon ingestion in certain numbers exert health benefits beyond inherent basic nutrition. They have been shown to reduce intestinal inflammation in the inflammatory bowel diseases, Crohn’s disease (CD) and ulcerative colitis (UC). Probiotics are effective in the treatment of acute pouchitis and its prevention. Their use also appears to have some effect in the management of active intestinal inflammation in UC and preliminary results suggest a role in the maintenance of remission.

Therefore the purpose of this study is to determine what effect the probiotic VSL#3, in addition to standard drugs, has on maintaining remission in Crohn’s disease in Australian patients. This study also aims to determine whether treatment with VSL#3 leads to an improvement in the quality of life, and also to assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it occurs. Up to 100 people with Crohn’s disease will take part in this study.

This study is being conducted by Dr Ian Lawrance and the probiotic VSL#3 will be provided free of charge by Orphan Australia.

Official Title

Conditions

Potential benefits of participating in the study:There are no direct monetary benefits to you by participating in this study, as your participation is required to be voluntary. However, by participating in the study, you may contribute to science. In addition, the data collected may be used to make important decisions about the funding of new medical treatments, by providing information that has been gathered from real Australian patients. Potential risks of participating in the study:Available clinical studies have demonstrated no significant side effects in individuals taking VSL#3, although a minority have complained of flatulence (gas) or bloating. The blood test can be associated with discomfort and bruising, as you would know from previous experience of such tests. There are no other risks in taking part.Confidentiality and Disclosure of Information:Any information obtained in connection with this project that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. If you give us your permission by signing the Consent Form, we plan to publish the overall results (for all patients together) in a scientific and/or medical journal. In any publication, information will be provided in such a way that you cannot be identified. Your personal information will be treated as strictly confidential and will not be made publicly available. At the beginning of the study, you will be given a study code number. All information collected during the study will be identified with your study code number and you will remain anonymous. Only the doctor and nurse will know who you are. The people analysing the results and the company sponsoring the study will not know who you are. If the results of the trial are published, your identity will continue to remain confidential.Results of the project:The overall results of the study will be available to be discussed with you after the study’s completion. If you would like to have that information, please ask the researcher or your doctor to discuss it with you.

Study Type

Randomised, Double-Blind, Placebo-Controlled Study

Study Design

What is involved if your participate?At your routine visit to the clinic, you will be asked to do the following:

• Answer questions about your symptoms (as the doctor would normally do);
• Have a routine examination by the doctor;
• Fill out questionnaires that will ask questions about you, your Crohn’s disease, and your quality of life. It will also ask questions about your use of health care for the treatment of your Crohn’s disease. The questionnaires will take about 30 minutes to complete and will be repeated every three months until the end of the study at 12 months.
• If you are already taking a proprietary formulation of probiotic you will be required to stop taking it two weeks before starting the trial preparation. Yoghurt without added probiotics can be continued and is not prohibited.
• You will be randomly assigned by a computer program to receive VSL#3 or placebo. (The randomisation will be allocated by the pharmacy at Fremantle Hospital to maintain the blinding of both patient and treating physician).
• Take a sachet of either VSL#3 or placebo twice a day orally for 1 year.
• Have a physical examination every three months.
• At each visit be given a diary card to fill out daily for the next 7 days. On this diary card, you will be asked to record your symptoms (such as diarrhoea, stomach pain and well being).
• Have a blood test every three months (as you would have for routine check-up) until the end of the study at 12 months.

That ends your involvement with the study.

Further Details

This project will be carried out in according to the National Statement on Ethical Conduct in Research Involving Humans (June 1999) produced by the National Health and Medical Research Council of Australia. The Human Research Ethics Committee of the Fremantle Hospital has approved the ethical aspects of this research project.Before you decide to participate it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends, relatives and your primary care physician(s) if you wish. Take time to decide whether or not you wish to take participate.

Study Start

May and will remain open until at least December 2005

Eligibility & Criteria

Who is eligible?People diagnosed Crohn’s disease between the ages of 18 – 65 years of age, male and female, living in and around the city of Perth.

Total Enrolment

100

Contact Details

Further Information or Any Problems:If you require further information or if you have any problems concerning this project, you can contact and one of the following individuals;The Research Coordinators: Beth Vener: (08) 9431 2698 Jill Philpott: (08) 9431 2698The Principle Investigators: Dr John Ombiga: (08) 9431 3333 Dr Ian Lawrance : (08) 9431 3333If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact Ms Wendy Khoo, of the Fremantle Hospital Human Ethics Committee on (08) 9431 3333.