Coeliac vaccine trials world

Here is an interesting item that my dear brother Jon sent me –

 Australian researchers are attempting to create a new treatment for coeliac disease, writes Margaret Pincus | March 21, 2009 Article from: The Australian IN 2002, Krishna Stanton ran into the stadium in the Commonwealth Games marathon in second place, behind friend and fellow Australian Kerryn McCann. As Stanton raised her hands to cross the finish line, the cheering crowd in Manchester, northern England, had no concept about what it had taken her to get there. And Stanton herself was unaware that a serious lifelong disease was causing the chronic ill health that had more or less derailed her athletic career. The marathon, it seems, was the easy part. It wasn’t until 2004 that Stanton was diagnosed with coeliac disease, a digestive auto immune disorder in which gluten — a protein found in wheat, rye, barley and oats — causes the body to produce antibodies that attack the lining of the small bowel. Like many people with coeliac disease, Stanton was affected in a variety of ways. Even as a child she was skinny with spindly legs and “a little pot tummy”. During her athletics career she endured chronically low iron and calcium levels, 15 stress fractures — some severe enough to require bone grafts — and chronic constipation and diarrhoea, which permanently damaged her large bowel. Eventually her bowel prolapsed, which made training almost impossible. Finally, when she was almost too exhausted to get out of bed, she was diagnosed with chronic fatigue syndrome. She now knows all these symptoms can be traced back to undiagnosed coeliac disease. “I just thought that feeling ill was normal,” says Stanton. Until now, the only treatment has been lifelong avoidance of all foods containing gluten, which is more difficult than it sounds because wheat flour and gluten are surprisingly common. So it is significant that next month Bob Anderson from the Walter and Eliza Hall Institute of Medical research in Melbourne is starting the world’s first trials of a coeliac vaccine that, if successful, could mean the end of gluten-free diets for people with coeliac disease. Last month, the British Medical Journal highlighted coeliac disease as a condition that may be commoner than doctors think, easily mistaken for something else (BMJ 2009;338:a3058). One per cent of Australians are affected but many do not know. The symptoms can be vague and can vary between individuals. Constipation and/or diarrhoea, bloating, anaemia, fatigue and osteoporosis are common. The Coeliac Society of Australia calls it a “hidden epidemic” because 80 per cent of people with the disease don’t know they have it. Do the maths, and that means about 200,000 Australians are unaware they have coeliac disease. And this is a worry, because long-term risks for untreated coeliac disease are serious. They include malnutrition, infertility, osteoporotic fractures, liver failure and cancer. Anderson refers to the vaccine as a “next-generation desensitisation therapy”. The treatment has been successful in mice and is now ready to be tested on humans. A trial is due to begin in April, although it will be what is known as a preliminary or phaseI study. The vaccine will be tested on 40 volunteers with coeliac disease over 11 months to establish that it does not harm them. In a subsequent phase II trial, which is designed to find out if the treatment is effective, volunteers will receive the treatment and then be challenged with foods containing gluten. Their immune response and intestines will then be examined to see if a tolerance to gluten has developed. The therapy involves repeatedly injecting solutions of gluten at increasing concentrations. The aim is to desensitise the subjects slowly, in a similar way to hay fever and dust allergy desensitisation treatments. Geoff Withers, director of pediatric gastroenterology at Brisbane’s Royal Children’s Hospital, says if the treatment is successful it could have global consequences for treatment and transform the lives of those with the condition. “A gluten-free diet is notoriously difficult,” Withers says. “It is expensive and lifelong, and comes at a cost to the individual.” Withers says his patients’ lives are changed by having to follow such a strict and limited diet. Some say they can’t eat with friends or go to the tuck shop, and in some cases families have given up on vacations because the diet is too difficult to organise away from home. “People with coeliac disease can never eat wheat again. “This is a difficult diet they have to manage every day for the rest of their lives.” Adopting a gluten-free diet is particularly difficult for children and teenagers. Donna Boston, whose 15-year-old son Edward was diagnosed six months ago, says the teenager is still “very angry about it — he just wants to eat what everyone else eats”. “When he goes surfing or to barbecues on the weekends, I have to make him a packed lunch because you just can’t buy gluten-free foods easily,” Boston says. “And being 15, food is a big thing for him just now.” To make matters worse, gluten turns up in unexpected foods. It’s not just the bread, pasta and cakes that contain gluten. “Soy sauce, sausages and lollies are all made with wheat; even sushi is a problem because the chicken is often crumbed,” says Boston. The fact that gluten avoidance has been the main treatment — albeit a costly and unpopular one — has made research into coeliac disease a low priority. “Because the diet has been effective, there hasn’t been a lot of support for research, but people don’t realise the significant morbidity and cost to the individual,” says Withers. Anderson agrees that coeliac disease “has been considered a done deal”. “But in reality the treatment is far from a done deal. Even with the diet, 50 per cent of people have intestines that don’t heal because compliance is difficult, and that means a higher cancer risk. And research has shown that the risk of death is three times higher in people with untreated coeliac disease.” Also promising is the fact that Anderson’s research provides a model for other immune and allergic disorders. “Coeliac disease is a wonderful opportunity because it is a model for a vaccine for other immune conditions such as type 1 diabetes, rheumatoid arthritis and multiple sclerosis. “In none of these other conditions can you be re-fed the antigen — but it is not that hard to convince people to eat gluten and feel a bit unwell for a while,” says Anderson. The road to the development of this treatment has not been easy. Anderson is that rare mix of a medical doctor (he’s a gastroenterologist) and a scientist (he has a PhD) who is able to make the link between the bedside and the laboratory to develop practical treatments. After struggling with funding throughout his research career, he took out a patent and co-founded a commercial company (Nexpep) to develop the vaccine himself. Stanton is enthusiastic about the prospect of a vaccine. Before she was diagnosed, her health deteriorated so much that people thought she had cancer or an eating disorder, because she was so thin. Due to her training requirements, she was often eating bread, pasta and cereal — the very foods that make coeliacs ill. Her condition went unrecognised for years because even recently doctors thought coeliac disease was rare. But according to the Coeliac Society, it is twice as common as type1 diabetes or breast cancer. Although modern blood testing has made early detection accurate and efficient, many continue remain to undiagnosed. Symptoms can vary between individuals, with some experiencing no symptoms at all. But damage to the bowel and general health still occurs, with or without symptoms. “Many people with coeliac disease think they have irritable bowel syndrome,” says Withers. “They put up with chronic ill health for years without realising they could feel much better and be much healthier with proper diagnosis and a gluten-free diet.” Stanton agrees. “I didn’t know what it was like to feel healthy. It took a simple blood test to alert my doctor and now I can say I’ve never felt better.”

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