Pylobactell

Описание товара

About Pylobactell

Pylobactell is a diagnostic test available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.

What it is used for

Pylobactell is used to diagnose Helicobacter pylori (H. pylori) infection in the stomach and duodenum (the part of the gut just below the stomach). H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach) and peptic ulcer disease (ulcers in the stomach or the duodenum). The medicine can only be obtained with a prescription.

How it is used

Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit. These samples are then sent for analysis at a specialised laboratory. To carry out the test, the patient must collect six breath samples, three before taking the Pylobactell tablet and three after taking it. The patient should fast for four hours before the test so that it is done on an empty stomach. If the patient has eaten a heavy meal then they should fast for six hours before the test. First, the patient takes a ‘test meal’ (such as 200 ml of pure undiluted orange juice). Five minutes later, the patient collects three breath samples. After a further five minutes, the patient takes the Pylobactell tablet dissolved in water. Finally, 30 minutes later (40 minutes after the test meal), the patient collects a further three breath samples. For full information on how the test is carried out, see the Package Leaflet. Pylobactell is not recommended for use in patients below 18 years of age because there is insufficient information on its effectiveness in this group.

How it works

The active substance in Pylobactell, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C). This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature. H. pylori produces enzymes called ureases that break down urea into ammonia and carbon dioxide. The carbon dioxide is then removed from the body in the breath. If the patient has H. pylori, the 13C-urea contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13C. This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry. If there is an increased level of labelled carbon dioxide in the breath sample after 30 minutes (a positive test), the patient may have H. pylori in the stomach or duodenum. If there is no increased level of labelled carbon dioxide in the breath, the patient might not have H. pylori in the stomach or duodenum.

Active substance: 13C-urea

Source: EMA EPAR