How might gluten degrading enzymes fit into coeliac disease?
Coeliac disease is an autoimmune illness caused by dietary gluten. Currently the only treatment for coeliac disease is the life-long avoidance of foods containing gluten. Persistent disease inflammation that might result from inadequate adherence to a strict gluten free diet may be associated with medical complications such as anaemia, osteoporosis, other autoimmune diseases, cancer and infections.
Gluten degrading enzymes are not medicines designed to treat coeliac disease. It is important to note that there is currently no product approved as a registered medicine for coeliac disease in Australia. Below is an explanation about the classifications used in the Australian Register of Therapeutic Goods.
Medicines
All medicines supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Medicines will be either registered or listed in the ARTG. You can tell whether a medicine is registered or listed by the AUST L, AUST L(A) or AUST R number on the label (this is the ARTG number for the medicine).
- Registered medicines are always evaluated for efficacy (that the medicine can do what it says it will) before they go on sale.
- Not all listed medicines are evaluated for efficacy.
You can look for the following on your medicine:
- AUST L listed medicines, which have not been assessed for efficacy.
- These products cannot make any high-level health claims relating to disease management.
- AUST L(A) assessed listed medicines,
- these have had their health claims assessed for efficacy.
- AUST R registered medicines,
- these have been through a rigorous assessment for safety, quality and efficacy before they go on sale.
- All prescription medicines will be ‘registered’.
Intraluminal Therapies (including Enzyme Supplements)
The group of therapies that aim to target gluten in the gastrointestinal tract and reduce the load of gluten stimulating the immune system are called intraluminal therapies. There are three different types:
- Endopeptidases or glutenases, which are enzymes that break down gluten
- Polymeric binding agents, which aim to bind gluten to prevent its action
- Tight junction regulators, which aim to reduce gluten passage across the gastrointestinal lining
There are a number of gluten-degrading enzyme supplements available in Australia or online. These include, but are not limited to:
- Glutagen, GluteGuard
- Doctor’s Best, Gluten Rescue
- Now, Gluten Digest
- Enzymedica, GlutenEase
- MRM Nutrition, Gluten Aid
Where does Gluteguard fit in?
GluteGuard is an enzyme product developed and manufactured in Australia by Glutagen Pty Ltd. GluteGuard differs in 2 ways from many other listed enzyme supplements.
- Glutagen has data from 2 published small clinical trials finding that the combination of enzymes in GluteGuard may assist in reducing the occurrence of symptoms experienced by people with coeliac disease, if exposed to small amounts of gluten.
- GluteGuard is a listed medicine (defined above) on the ARTG. The Therapeutic Goods Administration permits GluteGuard to state: “Helps reduce occurrence of symptoms of medically diagnosed gluten sensitivity caused by inadvertent gluten ingestion”.
GluteGuard is not a drug which needs to be broken down, metabolised and cleared through the liver. It is an enzyme supplement, which is a protein. Like any protein it will eventually be digested in the gastrointestinal tract like other food proteins. There are no gluten containing ingredients used in the manufacturing of GluteGuard and the main enzyme, Caricain, is sourced from the latex of green papaya skin. Any contra-indications to its use have been stated on the product packet.
Glutagen Pty Ltd, advises:
- GluteGuard is not intended to treat or cure coeliac disease or any other medical condition and therefore should not be used to replace a strict gluten-free diet.
- The intended use of GluteGuard is as an adjunct (in addition) to a strict gluten free diet. This enzyme can digest (break down) small amounts of gluten. By doing this it been shown to help reduce the symptoms of inadvertent gluten ingestion in individuals suffering from medically diagnosed gluten sensitivity.
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- Inadvertent gluten ingestion may result from cross contamination and accidental ingestion, such as might occur when travelling, eating out or when meals are prepared by others.
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Coeliac Australia advises:
- People with coeliac disease who choose to use GluteGuard must continue to maintain a strict gluten-free diet and not deliberately ingest gluten, when using the product
- Deliberate consumption of gluten when using GluteGuard is potentially unsafe even if you do not experience adverse symptoms.
- Ongoing management of coeliac disease, under the care of your medical team, is very important.