Can I Use Gluten Digest Like Products If I Have Celiac Disease?

Quite simply the answer is a big NO!!!!!! 

These products however are NOT suitable for those with celiac disease, even though there are some claims in the media that some celiacs have seen improvement when taking the enzymes. Don't risk it.

A number of gluten digest supplements currently on the market claim to break down gluten after it has been consumed.  But are these claims accurate or misleading?  Do these supplements offer a safe alternative to a gluten free diet for people who suffer from celiac disease and/or gluten-sensitivity or any of the other wheat/gluten related conditions? Do these products help people who need to go on a gluten free diet?

With the rise in the number of people being diagnosed with celiac disease and an increased awareness of gluten free issues, and the explosion of gluten free products available on the market, it is no surprise that gluten digest supplements claiming to break down gluten would find their way onto the market. But celiacs beware – they are not suitable for you!

So what are these gluten digest-like products? Well they are supplements which contain digestive enzymes which break down gluten. Examples are:

1.          GlutenEase 

GlutenEase, made by Enzymedica Inc., which contains a blend of enzymes that are claimed to help the digestion of both gluten and casein, a protein found in milk, according to the company. GlutenEase™ contains Protease Thera-blend™ (G1) along with dipeptidyl peptidase-4 ,DPP-IV, activity for enhanced digestion of foods containing gluten and casein as well as starch-digesting amylase enzymes to assist in the digestion of the carbohydrate portion of grains, such as wheat, which contain gluten.

The website for GlutenEase says that the supplement can "support" people who have trouble digesting gluten and/or casein resulting in discomforts like occasional gas and bloating. However, and most importantly, the site says that GlutenEase is "not formulated" for people with celiac disease: This product is not intended to replace a gluten-free diet for individuals with celiac disease.

2.       Gluten Defense 

Gluten Defense is made by Enzymatic Therapy Inc., contains a similar blend of enzymes and includes DDP-IV, lactase and amylase. The site for Gluten Defense says the product is "specifically formulated to defend against hidden gluten" that can cause gas, bloating and indigestion. Gluten Defense helps you digest other proteins, fats and carbohydrates as well.

However, unlike GlutenEase, Gluten Defense offers no specific disclaimer for people with celiac disease. There is also no claim that the product is safe, or in any way formulated for people with celiac disease. But do not use these enzyme supplements if you have celiac disease.

3. Gluten digest 

Gluten Digest is manufactured by NOW International. The company claims that this product helps to digest gluten and cereal grains.  It contains Gluten Digest, with BioCore® DPP IV (Dipeptidyl peptidase IV),  a digestive enzyme which specifically breaks apart difficult-to-digest proline-containing peptides, which are generally known to come from dairy products and cereal grains.  Gluten digest also contains amylase and glucoamylase enzymes that assist in the breakdown of carbohydrates as well as proteases.

The company does give a caution however:  If you have Celiac Disease, use Gluten Digest only under your practitioner's supervision. They also state that any statements have not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

 Do the claims made by the manufacturers of these "gluten digest" products mean that taking the supplement might offer people with celiac disease some extra protection when they are exposed to accidental gluten contamination?

The answer is that there is NO proven scientific evidence to say that this is the case and those with celiac disease really cannot afford to be blasé about it. The fact is that there is no guarantee that these supplements will break down 100% of the gluten so the risk is too great for celiacs. Even a trace of gluten can cause damage in a celiac so in order for it to work it would have to break down 100% of the gluten BEFORE it contacts the intestinal walls. This is NOT possible. The fact is that these enzyme supplements may break down a few molecules of the gluten protein, but no supplement exists that will make it safe for people with celiac disease to eat gluten again.

These products can be quite useful however for those people who do NOT have celiac disease, but who suffer from non-celiac gluten sensitivity. Non-celiac gluten sensitivity is thought to be due to the person's lack of ability to produce the right enzymes required to break down gluten in the intestine. Therefore people suffering from this condition lack the enzyme in their gut which is required to break down gluten so it can be absorbed through the intestine. It is similar to people who suffer from lactose intolerance.

To control the symptoms of bloating and other intestinal symptoms, people with non-celiac gluten sensitivity also need to go on a gluten free diet. For this group of people the ingestion of a little bit of gluten may cause discomfort but is not life threatening in the long-term.  These commercially available "gluten digest" products may  provide the missing enzymes so the person can eat gluten without suffering.  

Pharmaceutical companies are spending hundreds of millions of dollars in research to create an enzyme-based drug that would permit people with celiac disease to consume gluten.  So maybe one day this will be a reality for celiacs, but NOT YET. Talk with your doctor BEFORE making any changes to your gluten free diet for celiac disease treatment. A completely gluten free diet is currently the only proven treatment for celiac disease. Read my book today to learn how.

BUY NOW

Are Australian and NZ Gluten Free Food Manufacturers Disadvantaged By the Detection Limited Not Being Stated?

 In the past 5 to 10 years the regulations relating to gluten free food labeling in various countries have progressed substantially. More people have become aware of what it means to eat gluten free food and manufacturers have got on the band wagon and more and more gluten free foods are available for purchase from supermarkets and specialty health stores.

 Check out my top 10 tips to achieve gluten free food

For consumer safety most countries have established food safety laws to protect people with food allergies and other eating requirements such as celiac disease. The laws on the labelling of food as gluten free are very tight and businesses who label product as gluten free must comply with the law of that country. Food manufacturers have a legal obligation as well as a duty of care to ensure that the food they serve to customers is safe and this extends to customers with celiac disease.

If a product is labeled as gluten free food then the manufacturer has to be absolutely sure that it is 100% gluten free to comply with the law. Food businesses have to make sure that they have processes and systems in place to ensure that the information they provide is accurate and can be checked by you the consumer.

These legal regulations provide consumers, especially those with celiac disease, the assurance that a gluten free claim on food products are consistent and reliable across the food industry. The regulations give consumers a standardised tool for managing their health and dietary intake. The good thing about having labelling laws is that it assures people with celiac disease that foods labelled gluten free have met a clear standard established and enforced by the FDA or other authorities.

The leading international authority on the labelling of gluten free food is the Codex Alimentarius, which is recognised as "The International Food Standard" and most countries have based their labelling laws on their criteria. The Codex standard for gluten was revised in 2008 and has a two-step approach for the classification of gluten free labeling. It specifies:

1.    Products can be labelled gluten free only if they meet the following criteria:

                              I.        not derived from gluten containing cereals and containing maximum 20 mg/kg (ppm) of gluten

                            II.        derived from gluten containing cereals which have been specially processed to remove gluten and the gluten level does not exceed 20 mg/kg (ppm) of gluten in total

2.    Rendered gluten free for products, such as specially processed wheat starch based products, with reduced gluten content above 20 to at a level of 100 mg/kg (ppm). How these products are labelled for the consumer has been left at a national level, so they could also be labeled Low Gluten Level or Very Low Gluten Level

The USA , Canada, UK and Southern European countries have all in the past few years adopted gluten free standards which adopt the Codex level of detection, yet the FSANZ standard  for Australian and NZ combined standard still require that food labeled as gluten free contains no detectable gluten:

1.    GLUTEN FREE - A claim to the effect that a food for special medical purposes is gluten free may be made only if the food contains no detectable gluten; and if it does not contain oats nor oat products; and it does not contain cereals containing gluten that have been malted, nor the products of such cereals.

2.    LOW GLUTEN CONTENT - A claim to the effect that a food for special medical purposes has a low gluten content may be made if the food contains no more than 20 mg gluten per 100 g of the food. (200 ppm)

This regulation results in Australia and NZ having the strictest standards for the labeling of 'gluten-free' foodstuffs which are out of whack with international best practice. This is because the detection limit required in the FSANZ standard is not specified, and as technical methods improve, detection limits are and will get lower and lower. This standard creates unnecessary compliance costs for food manufacturers in Australia and NZ, and unnecessarily limits the range of foodstuffs available to people suffering from celiac disease and dermatitis herpetiformis.

"Detectable" is not defined in the Code or in any piece of Australian or NZ regulatory guidance. Despite this, Australia's Competition and Consumer Commission (ACCC) has expressed the view that 'gluten-free' ought to mean "absolutely no gluten whatsoever".

Also, there is no regulation on the testing methodologies used to test for gluten. The most internationally adopted method used to detect gluten in foods is the Gliadin ELISA test. The Limit of Detection (LOD) of this method which is determined by the manufacturer is 3 ppm. 

However the sample itself can interfere and make testing at this low level unreliable. It is therefore currently generally accepted that the minimum level of gluten that can be accurately quantified across a range of different food matrices using recommended ELISA methods is 5ppm which is the Limit of Quantitation (LOQ).  Hydrolysed and fermented products require a different testing method and the LOQ may go up to around 10ppm.

This means that foodstuffs labelled as 'gluten-free' in Australia and NZ are effectively required to contain no traces of gluten over 3-5 ppm depending on the method used. This is in comparison to other countries where the detection limit is < 20 ppm. There are concerns that in the future, improvements in detection technology may result in even lower detection limits becoming possible, such as  <1 ppm. Developments of that kind may result in a further contraction in the range of products available to those with gluten intolerance in Australia and NZ.

Australian and NZ health professionals are divided on the issue of the toxicity of oats and malt in individuals with celiac disease.  NZ health professionals consider that small amounts of oats and malt can be consumed by people with celiac disease. Conversely, Australian health professionals believe that there are some people with celiac disease that are unable to tolerate even the smallest amounts of oats and malt.  This standard takes into consideration the opposing views of Australian and NZ health professionals in terms of the toxicity of oats and malt and the dietary management of celiac disease.  

The level of 20 ppm gluten being defined as gluten free has been internationally accepted as been safe by medical experts. There is no evidence that this level of gluten causes any problem for a person with celiac disease. To the contrary, gastroenterologists worldwide have confirmed that a foodstuff containing <20 ppm of gluten is considered safe for celiacs. This view is consistent with leading scientific studies commissioned by Codex and others, which conclude that safe levels for gluten ingestion by celiac disease sufferers are actually much higher than the Australian and NZ's standard suggests. However, there are some professionals who argue that 10 ppm or less would be safer levels for celiacs.

I believe that Australia and NZ need to adopt the CODEX definition to give a level of international uniformity and to keep up with the regulations in other countries. It is essential that the international definition of gluten free is both achievable in commercial food manufacturing processes but it also needs to be safe for those with celiac disease.  It is also essential that the term gluten free is synonymous throughout the medical profession worldwide when discussing the treatment for celiac disease. The internationally accepted level of 20 ppm will achieve all these goals.

Australia and NZ food manufacturers are currently disadvantaged by these laws. It is just not the added cost of compliance, but if they export overseas they have to change the labeling on their products to meet international regulations. It makes sense that the gluten free standard in Australia and NZ should be the same as the widely accepted international standard of less than 20 ppm (parts per million) which has been adopted by the UK, Southern Europe, the USA and Canada; 20 ppm of gluten is a tiny amount equivalent to 0.002% of gluten in a product.

These countries adopted this standard after lengthy and rigorous scientific assessment which took into account the weight of scientific evidence, clinical observation and international expert medical opinion which all supported 20 ppm as a safe threshold for people with celiac disease. If it is not addressed soon, testing methods may become so sophisticated and sensitive to the detection of gluten that the gluten free food space in Australia and NZ could soon become near impossible for manufacturers to compete in. 

 Manufacturers - make sure your products comply with the law

Is the Simtomax, Point-of-care (PoCT) Test For Celiac Disease Worthwhile?

Last year, Sigma Pharmaceuticals (Sigma), launched the new Simtomax celiac disease in-pharmacy screening test in Australia. The test can quickly tell patients whether they could potentially have celiac disease or not. The new test, involves a small finger prick blood sample, which is then tested on site at the pharmacy and gives you results in 10 minutes. This new test for celiac disease is available exclusively at Amcal, Amcal Max and Guardian pharmacies in Australia. These pharmacies are all owned by Sigma. Simtomax is available in some other countries as well.

Research has found that celiac disease affects as many as 1 in 60 women and 1 in 80 men in Australia, but is often left undiagnosed due to non-specific symptoms and inadequate testing. Traditional testing involves a clinical history, blood tests sent off to be tested in a laboratory and a biopsy of the small intestine. It is surprising to think that up to 90% of Australian’s who suffer from celiac disease don’t even know they have it.  And that is a dangerous for their long term health.

Celiac disease is an autoimmune disease triggered by gluten in the diet. Left undiagnosed or untreated, people with celiac disease are at an increased risk of osteoporosis, pregnancy complications, cancer and other autoimmune conditions.

The new screening test is simple, non-invasive, readily accessible, and only takes about 10 minutes. Anyone can be screened in pharmacy for celiac disease without having to consult a doctor first. However if the testing is positive, the patient is advised to consult their doctor for follow up testing.

However specialists in the field have raised concerns about point-of-care (PoC) finger-prick testing for celiac disease, currently offered in 440 Australian pharmacies and currently being rolled out to doctors this year. Prior to testing a pre-screening questionnaire assesses symptoms and suitability.

In a letter to the MJA, gastroenterologists, Dr Evan Newnham and Dr Jason Tye-Din said the accuracy of the PoC test Simtomax was less than laboratory based tests, and interpreting the colored line that appears on the device can be difficult. he reports that false positive results occurred in about 10% of PoC celiac tests, with false negatives reported in about 15 to 20%.  Other reports I have read  indicate that the inaccuracy of the test may be even higher than this.

However, James Nevile, a spokesperson for Sigma, which owns Amcal and Guardian pharmacies, said the AU $45 test was not meant to be a diagnostic tool. “What we’re trying to do is drive patients toward seeing a GP. It’s certainly not about any removal of the role of the GP,” he said. And I believe that is good thing. 

However Dr Tye-Din, chair of Celiac Australia’s medical advisory committee and a researcher at the Walter and Eliza Hall Institute of Medical Research, Melbourne, said he was concerned about self-diagnosis, which “could potentially mean a lot of people are starting gluten-free diets unnecessarily”. This is because it is reported that the new Simptomax celiac disease in-pharmacy screening test is only 49% accurate when it comes to positive results, which means more than half the people the test says have celiac disease actually don't.

Despite this, I believe that PoC tests are a good indicator for someone with chronic bloating or tiredness especially those people who avoid going to the GP.  Anyone who had a positive test or persistent symptoms must be encouraged to see their GP for further testing.  Being encouraged to see a doctor is a good thing.

The fact that there is so many people with undiagnosed celiac disease is certainly a worry because these people can end up with life threatening illness, so anything that gets them to be celiac disease aware must be good in my view.  We need to reach out to these undiagnosed cases and get them to seek medical attention. A positive test will no doubt lead them on to seek medical treatment where an accurate diagnosis can be made.  But what about the false negative results?

  

Dr Sue Hookey, a Melbourne-based GP, said her greatest concern was with false negative results.
“People think they can keep eating gluten and this could have a real impact on their quality of life.”  

The validity of the test has not been proven as being reliable for a general population screening tool.  In fact, as of late last year, researchers at Royal Liverpool Hospital in the UK, when using the test on 112 patients at high risk of celiac disease,  recommended that it should not be used as screening test because it had low sensitivity (too many false negatives).

I also think that this is a huge risk because celiac disease is a great “mimicker” and could be missed if people who had a negative PoC test were not referred for further investigation as well. The symptoms of celiac disease are usually quite obvious. The symptoms of celiac disease could include any of the following:

 

·         Diarrhoea
·         Joint or muscle pain
·         Bloating/Abdominal pain
·         Heavy painful periods
·         Constipation
·          Headaches
·         Chronic mouth ulcers
·         Acne
·         Unexpected weight loss
·         Bulky stool
·         Itchy skin rash
·         Brittle nails

But if you are asymptomatic and do not have the obvious symptoms, celiac disease could be overlooked until it is too late to do anything about it? Some of the signs to look for and consider in asymptomatic celiac disease are:

• Pre-existing type 1 diabetes (10% also have celiac disease)
• A direct relative (parent, sibling) with type 1 diabetes or celiac disease
• Low iron
• Unstable glucose levels in diabetics
•  Growth issues in children

So to answer the question is the simtomax point-of-care (PoCT) test for celiac disease worthwhile? I believe the answer is yes because it raises people's awareness of celiac disease. However results should be interpreted with caution and any positive results followed up with proper testing from a doctor prior to the person starting on a gluten free diet.

A person with a negative result and obvious symptoms of celiac disease should also be encouraged to consult a doctor. The symptoms may or may not be due to celiac disease. It is important to get a proper diagnosis for the root cause of the problem and more sinister illness like bowel cancer and IBS - Irritable Bowel syndrome etc. need to be investigated as well as celiac disease. Only a doctor can do that.

If you are diagnosed with celiac disease the only treatment is to go on a gluten free diet for the rest of your life. If you need help transforming your home into a gluten free zone , read my book, "What is Gluten Free? it will give you all the guidelines you need to start your gluten free journey.