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Professor Richard S Stubbs MD, FRCS, FRACS - Managing Director & Investigator, P3 Research Ltd
 
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Clinical Trials in Inflammatory Bowel Disease - Help yourself and others.

Richard Stubbs MD FRCS FRACS, Managing Director and Investigator, P3 Research Ltd —

Some years ago, the emphasis in ulcerative colitis and Crohn's disease research was in the area of biologics for severe disease, which otherwise might have required urgent surgery.

Many New Zealanders participated in a variety of clinical trials conducted around the country on behalf of Pharmaceutical Companies. Many of these volunteers benefitted from the treatments being trialled, and, at the same time, helped others with severe disease by contributing to these trials and helping bring new medications to the market.

Today, the search for better biologic therapies for those with severe disease continues. Clinical trials in this area are regularly being conducted around the country, usually through hospital gastroenterology departments. Those with severe disease will likely be made aware of these options as they are being cared for in the public system.

However, there is also interest in developing new and better treatments to control mild to moderate disease. This is the much more common problem, where there has been reliance on using systemic immune-modulators (such Azathioprine and 6-mercaptopurine) and sometimes repeated use of steroids. While generally effective, this approach is less than ideal. New options are being explored involving the use of oral, non-absorbed medications, which immune-modulating molecules that act directly on the surface of the gut, aimed at avoiding the side effects of immune-modulators and high dose steroids. There is also a developing interest in the role of gut bacteria in the underlying mechanisms of many immune mediated diseases, including ulcerative colitis. The goal is to alter the gut bacteria (or microbiota, as it is called), with the intention of reducing inflammation. Initially these attempts involved the use of probiotics. Another way to alter the gut microbiota is with “faecal transplantation” in which stool containing bacteria from healthy individuals is introduced into the colon of patients usually at colonoscopy. The current and latest approach is to develop capsules containing spores of specially cultured bacterial species, which may be deficient in patients with ulcerative colitis, and which may have a role in enhancing protective mechanisms in the gut lining. Trials of these new preparations are now being conducted around the world for the less severe forms of the disease.

Opportunities to participate in clinical trials exist in a number of public hospital and private research sites around the country for those with poorly controlled disease of all severities. Participation in these trials may lead to benefits for both the participants and others in the future. If you wish to be included in one of these trials, keep your eyes and ears open for where such trials are being run, including on the Crohn's & Colitis New Zealand website current research page, https://crohnsandcolitis.org.nz/current%20research.

Before enrolling in any clinic study or research project, it is very important to first discuss it with your regular specialist provider. 


Richard Stubbs MD FRCS FRACS

Managing Director and Investigator, P3 Research Ltd, www.p3research.co.nz