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The key aims of treatment in ulcerative colitis are to stop inflammation in the large bowl so that healing can occur, and to prevent inflammation recurring. Unfortunately, in a small proportion of people with ulcerative colitis (around 1 in 8), the inflammation grumbles on despite treatment with our best currently available drugs, as situation called “chronically active ulcerative colitis”.

Not a satisfactory situation
Such a situation is unsatisfactory for several reasons. The first and foremost is that chronically active disease is associated with ongoing bowl symptoms – continuing to loose and frequent bowl actions with or without bleeding – and being generally tired and ‘under par. Secondly the drug therapy conventionally used to help keep the symptoms and inflammation sufficiently controlled to enable reasonable quality of life may have side effects that are of concern. This particularly applies to taking medication such as steroids (Predisolone or Prednisone) over a long period of time. Thirdly, ongoing inflammation is also not good for the body in other ways. For example, it increases the risk of thinning of the bones (osteoporosis), a risk that is made worse by taking steroids in anything but small doses. It can reduce your ability to extract and absorb iron from food and can lead to iron deficiency. Having poorly controlled bowel inflammation over a prolonged period can also increase the risk of getting bowel cancer and is one factor that might encourage your doctor to recommend regular and more frequent colonoscopy to keep an eye on things.

Options available
The traditional way of managing such a situation was to suppress the inflammation as best as we could with immune modulating drugs such as azathioprine, aminosalicylates (like sulfasalazine or mesalazine), and steroids, often in combination. In this situation, it is not unusual for people to take fish oil or complimentary medicines, and virtually to rattle when walking down the corridor. The other option is to remove the bowel by surgery and to have a permanent ileostomy (bag) or pouch. This is a highly effective therapy but not one that people find the easiest to accept because of its permanent and irreversible nature (you can’t put the bowel back later).

It is not surprising then that new ways of treating chronically active disease are or have been developed. One of the approaches has been to use infliximab, an antibody that is given by intravenous infusion (that is slowly dripped into a vein). Infliximab has been approved for the use in adults with moderate to severe ulcerative colitis who have inadequate response to conventional therapies. Unfortunately, this therapy is very expensive and, because it is not currently funded by the Government, most people in New Zealand cannot access infliximab for their chronically active ulcerative colitis.

A new kid on the block
A new drug that works in the same way as infliximab is currently being evaluated across the world. Like infliximab, this drug, golimumab, is an antibody, but unlike infliximab, it can be given intravenously or subcutaneously (that is, injection under the skin) and thus provides more flexibility in the route of administration. There are several centers across New Zealand taking part in a clinical trial to evaluate golimumab. The trial is designed to see if there is a reduction in signs and symptoms, and an increase in quality of life for patients with ulcerative colitis. In order to find out scientifically how effective golimumab is, some people who participate in the trial will receive a placebo (dummy drug). Neither the participant nor the treating doctor will know whether a participant in the study will receive that active study treatment (i.e golimumab) or the placebo (i,e the dummy drug). This is called ‘double-blinding’ and is an essential part of how clinical trials are carried out. If the study treatment is not working, then there is an option later on, in the follow up study to receive treatment with the active study treatment, that is golimumab for sure.

We hope that this and other initiatives will lead to effective new options for routine clinical practice in people with moderate to severe active ulcerative colitis in the future.



Crohn’s and Colitis New Zealand Study Listing

A Phase 2/3 Multicentre, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Purpose
The purpose of this trial is to determine if treatment with experimental drug (golimumab) that is subcutaneously (under the skin) administered can safely and effectively reduce the signs and symptoms of active ulcerative colitis (such as diarrhea and rectal bleeding) better than treatment with placebo. A placebo is an inactive or dummy treatment that looks the same as the study drug but does not contain any active medication. Golimumab is not licensed for use in ulcerative colitis.

Study Design
About 676 people will participate in the study at approximately 150 centers. Particpation in the study will last for six weeks. Participants will receive multiple injections (under the skin) of placebo or golimumab. At week six participants will be asked to take part in an additional 54-week maintenance study called C0524t18 and a long-term extension study that will last approximately three years. If the participant chooses to take part in the maintenance study, his/her participation in this study will extend 16 weeks after the last dose of study medication.

Eligibility
Men and women, 18 years of age or older

Criteria
If you meet the following criteria (there are other criteria not listed) you may qualify for this study:

• You must have had a biopsy with a diagnosis consistent to moderately to severly active ulcerative colitis.
• You must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least one of the following therapies: oral 5-ASAs, oral corticosteroids, 6-mercaptopurine (6MP) and azathioprine (AZA) or have a history of corticosteroid dependency.

In addition, you can not:

• Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry.
• Have ulcerative colitis limited to the rectum only or to <20cm of the colon.
• Have a stoma.
• Have a history of a fistula
• Have previous exposure to anti-TNF therapies (such as infliximab or adalimumab).

If you are interested in participating in this study and would like more information, please contact the Investigating Site nearest to you (as follows).

1. Dr Frank Weilert, Waikato Hospital. Study coordinator, Nancy Sullivan (07) 839 8899 ext 8070
2. Associate Professor Murray Barclay, Christchurch Hospital. Study coordinator, Rhondda Brown (03) 364 0135
3. Dr Michael Shultz, Dunedin Hospital. Study coordinator, Paula Cooper (03) 474 7966

Mountain Motion is a climbing team formed by Kiwi's Vaughn Filmer and Jamie Anderson, both passionate outdoor enthusiasts and aspiring filmmakers. With extensive experience tramping and climbing in New Zealand¹s Southern Alps, we are set to take on a greater personal challenge in the mountains. Our most recent adventure was a traverse of Mt. Earnslaw, an achievement made significant for us as Vaughn was coping with the symptoms of Ulcerative Colitis (UC). A form of Inflammatory Bowel Disease (IBD), which includes Crohn's, UC produces symptoms such as lethargy, cramps and frequent bowel motions and requires significant modifications to diet and lifestyle. Dealing with this condition but still actively climbing gave us the inspiration to embark on a mission that will test our limits in New Zealand¹s mountains and raise awareness of IBD.

Approaching 30 is our mission to climb the 30 highest mountains in New Zealand in the summer of our 30th birthdays and promote the work of the New Zealand Crohn's and Colitis Support Group (Inc.).

The NZ CCSG uses www.everybody.co.nz as the forum for discussion amongst members living with Inflammatory Bowel Disease. Mountain Motion will look to post updates and information about the adventure on this fantastic website.

MOUNTAIN MOTION Approaching 30. The Mountain Motion team will use their live website,www.mountainmotion.co.nz, to update the public and sponsors of Approaching 30 progress using images, videos and humorous anecdotes. During and after the adventure they will write articles for publications.

World-first living intestine study points to new generation of food and medicines

Scientists from Massey University have discovered a weak link in human digestion that could revolutionise healthy eating and medical treatment for the chronically ill.

The universities digesta group, a multi-disciplinary team of researchers, have for the first time been able to analyse the work of the small intestine, the principle organ of digestion and absorption. Associate Professor Roger Lentle says that, until now, the only way to understand what was going on was by mathematical simulation.

Doctor Lentle’s team of scientists is the first in the world to measure the extent of mixing in a section of living intestine that is kept alive in a tank that simulated normal conditions in the body. Intestine from a possum, a mammal with an intestine that was large enough to measure the mixing was used.

The team used a complex system of coloured pulses of material to measure the level of mixing along with video imaging and computer software and frame-by-frame analysis to measure movements of the intestinal wall. Unlike the mathematically produced results, which indicated that mixing was poor, the small intestine was found to produce quite good levels of mixing. This was partly due to a jerky motion of the muscles in the intestinal wall that helped to create a turbulent environment, and to the colon of the small intestine inside the belly.

A key finding that is important for the design of foods is that any increase in the thickness of food within the small intestine significantly impaired mixing.

“This indicates that foods which are designed to thicken when they enter the small intestine will not mix and digest well and thus will be slower to release their load of glucose or fats,” Doctor Lentle says. “An example of a potential future application is a new drink which you may have in the morning, with your bacon and eggs, which thickens when it reaches the intestine to stops or slows absorption of the fats. Drinks could also be developed to impair the absorption of glucose and cholesterol.

The findings also bode well for sufferers of intestine diseases including Crohn’s disease, or Ulcerative Colitis. Some drugs used for treating these conditions need to stay within the small intestine, Doctor Lentle, so a drink could be formulated to take with the medicine to ensure the drug is not prematurely absorbed.

“So the medicines end up in the place where they can do most good,” Dr Lentle says. “A further use is in getting Probiotics [dietary supplements containing potentially beneficial bacteria] to the lower bowel, which is where they can do the most good, by preventing them from being killed on their way through the small intestine by mixing with bile salts.”

As well as commercial applications, the research has shown for the first time that a physical form of food has the potential to slow digestion and improve glycaemic index, by influencing mixing in the small intestine rather than by simply delaying the emptying of the stomach, as had previously been thought.

The work was made possible when the team, based at the University’s institute of Food, Nutrition and Human Health, developed a new electronic spatiotemporal mapping technique that enabled them to simultaneously measure lengthwise and widthwise changes in the living intestine. Fives pictures of the gut per second were captured on video and electronically processed to generate movement maps of the intestine. The findings are currently being published in The Journal of Physiology.

This is a summary article only from Massey University, New Zealand