Recent headlines proclaimed an Australian-developed pill might help those with coeliac disease eat wheat without becoming ill.
The pill, GluteGuard, was developed by the Melbourne-based biotech company Glutagen. It contains an enzyme called caricain, found naturally in papaya, which can break down proteins, including gluten.
But GluteGuard is not suitable as a treatment for coeliac disease. This position is supported by Glutagen’s disclaimer, which states the product is not a suitable replacement for a gluten-free diet and should not be used to “treat, prevent or cure” any disease.
According to Coeliac Australia, the only treatment for coeliac disease is “the strict, life-long avoidance of foods containing gluten”. The potential complications of consuming gluten for people living with coeliac disease are serious and include osteoporosis, anaemia and some cancers.
Remind me, what is coeliac disease?
Coeliac disease is an autoimmune condition, where sufferers react to gliadin, one of the two proteins that make up gluten. Gluten – the substance that gives wheat dough its stretch – causes the immune system to destroy the microscopic villi (the finger-like lining) of our intestine which absorb nutrients from our food.
Non-coeliac gluten sensitivity is a wide range of conditions that can mimic the diarrhoea, discomfort and bloating seen with coeliac disease. However, it does not result in antibodies appearing in the blood or the damage to the intestine typical of coeliac disease.
Non-coeliac gluten sensitivity can often be mistaken for irritable bowel syndrome (IBS). Although people with IBS are often advised to use gluten-free foods, this is not related to the gluten. Instead it is linked to particular carbohydrates that people with IBS struggle to digest, which are known as FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols). FODMAPs are often found in grains containing gluten such as wheat, rye and barley.
Coeliac disease is diagnosed by a blood test and biopsy sample from the intestine. If tests are clear, IBS and non-coeliac gluten intolerance may be diagnosed.
What does the science say?
The Glutagen website says the product is designed to digest gluten.
But other sources suggest caricain is a general protein-digesting enzyme, meaning it could break down any protein, not just gluten. This isn’t necessarily a problem, but could influence the amount of enzyme needed if you’re also consuming large amounts of protein – for instance, in a burger.
It is possible that caricain enzymes could reduce the symptoms for someone with non-coeliac gluten sensitivity but is not an advisable treatment for coeliac disease. Although the enzymes may help break up gluten, it is unlikely that in people with coeliac disease it would be able to adequately digest dietary gluten enough to avoid risk of long-term damage.
At the moment, it is not a suitable replacement for a gluten-free diet.
GluteGuard is not unique; similar enzyme products have or are undergoing trials in Europe and the United States.
Research into GluteGuard and similar enzyme products shows some interesting initial findings. After taking enzyme pills, users with coeliac disease or non-coeliac gluten sensitivity may have improved tolerance to gluten, with fewer symptoms and possibly less damage to the intestine.
However, the control group (those who didn’t receive the enzyme pills) did not all get worse, so it’s hard to say definitively the enzyme pills are better than the dummy pills. The measurements of effects on the immune system (antibodies that recognise proteins in gluten) and intestines (damage to the lining) were inconsistent.
The quality of the research published, including work linked to the Australian product, which was carried out in Poland, could also be questioned. The researchers used a small number of patients; and the research design did not meet the expected standards.
If the manufacturer states the product should not be used to treat any disease including coeliac disease, how is it listed with Australia’s regulator, the Therapeutic Goods Administration (TGA) as a complementary medicine?
The scheme it is registered under states it should not contain a poison and only approved ingredients. This is a largely self-certified scheme, and so it only has to be safe and it does not necessarily have to work.
Small benefit for some
All this appears to have parallels with the A2 milk story. This milk does not help people with cow’s milk allergy or lactose intolerance, but may have some modest benefits for those who report being intolerant to milk protein.
The risk with both A2 milk and gluten digesting enzymes is that consumers choose these products thinking they will help their conditions, but they could in fact be harmful.
Although products such as these may have some benefits, they’re likely to be useful only for a small group of people. And at just under A$45 for 60 tablets, GluteGuard is expensive to try.
Instead, people with coeliac disease should aim to maintain a strict gluten-free diet.