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 or intended 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.

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.

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.

Small benefit for some

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.

This article was amended to clarify several passages in response to additional information supplied by Glutagen. We have also commissioned another perspective on this topic more broadly, and you can read it here.

Response from Dr Jim Rothel, a director of Glutagen:

It is a shame that the author of the article above did not seek comment from Glutagen before publishing. This article simply misses the point – GluteGuard is intended as an adjunct to a gluten free diet not a replacement for such a diet. It is not designed to encourage users to consume gluten but rather is a protection against unintentional consumption and cross contamination. The only current treatment for coeliac disease is adherence to a gluten-free diet. Similarly, the best treatment for those with non-coeliac gluten sensitivity (NCGS) or gluten-related IBS is a gluten-free diet. However, those with these conditions will know that it can be common for people on a gluten-free diet to get “glutened”, by the inadvertent consumption of gluten contained in a supposed “gluten-free” meal. Indeed, published studies have demonstrated that more than 91% of coeliacs report inadvertent gluten consumption on a regular basis! So the problem GluteGuard addresses is one of a life-style issue imposed on those with gluten sensitivity by their condition. Eating out at restaurants, when travelling, whilst in hospital and dining at a friend’s or families’ homes are all examples of when preparation of gluten-free meals may be compromised. What did GluteGuard’s trial show? In the GluteGuard trial more than two thirds of the control group (those who didn’t receive GluteGuard tablets) withdrew from the trial due to severe symptoms following a gluten challenge (ie after consuming small amounts of gluten on purpose). The measurements of the effects on the immune system (antibodies that recognise proteins in gluten) and intestines (damage to the lining) showed a statistically significant difference between those taking GluteGuard and those on the placebo. Importantly, those taking GluteGuard reported significantly fewer symptoms following gluten challenge than those taking the placebo. The author also misstates the nature of TGA regulations and ignores the fact that all claims made in relation to GluteGuard (including its ability to breakdown gluten) need to have ( and do have) proper scientific support. So how does GluteGuard help? In situations where a person cannot be sure that their meal is totally gluten-free, taking a GluteGuard tablet before the meal may protect them from the consequences of inadvertent gluten consumption. It is a safety measure for those gluten sensitive individuals, helping them to live life with less worry and concern about eating an inadvertently contaminated meal whenever food preparation is out of their control. It is not a tablet that allows gluten sensitive people to consume gluten on purpose. It is an adjunct to a gluten-free diet that can provide significant benefits to wellbeing and lifestyle of those who are gluten sensitive.

About Dr Jim Rothel: Jim Rothel, B.App.Sci, M.App.Sci, PhD. Is a Director of Glutagen, former Founding Director and Chief Scientific Officer of ASX listed Cellestis Limited. Jim was a co-recipient of the Clunies Ross Award from the ATSE in 2013