What is Pylobactell?
Pylobactell is a diagnostic test. It is available as a kit that includes a white soluble tablet containing 100 mg of the active ingredient 13C urea.
What is Pylobactell used for?
Pylobactell is used to diagnose Helicobacter pylori ( H. pylori) infection in the stomach and duodenum (the first part of the small intestine). H. pylori is a bacterium that contributes to the appearance of diseases such as dyspepsia (gastric acidity, abdominal bloating and nausea), gastritis (inflammation of the stomach) and peptic ulcer (ulcerative lesions of the stomach or duodenum).
The medicine can only be obtained with a prescription.
How is Pylobactell used?
Pylobactell is a breathing test: expiratory air samples are collected in the test tubes contained in the kit. These samples are then sent to a qualified analytical laboratory.
To perform the test the patient must collect six breath samples, three before taking the Pylobactell tablet and three afterwards. The patient must remain fasting for four hours before the test, in order to do it on an empty stomach. If the patient has consumed a heavy meal, he must remain fasting for six hours before performing the test.
The patient must first consume a "test meal" (for example 200 ml of undiluted pure orange juice). After five minutes, the patient collects three breath samples. After another five minutes take the Pylobactell tablet dissolved in water. Finally, after 30 minutes (ie 40 minutes after the test meal), the patient collects three more breath samples. For more information on performing the test, see the package leaflet.
The use of Pylobactell is not recommended in patients under the age of 18, as there is insufficient information on the efficacy in this category.
How does Pylobactell work?
The active ingredient of Pylobactell, 13C urea, is the natural chemical urea labeled with carbon 13 (13C). This means that it contains 13C, a rare form of the carbon atom, rather than carbon 12 (12C), the most widespread form in nature.
H. pylori produces enzymes, called urease, which break down urea into ammonia and carbon dioxide. Carbon dioxide is then eliminated from the body in the expired air. If the patient has H. pylori in the stomach or duodenum, the 13C urea contained in the Pylobactell tablet is decomposed and the carbon dioxide in the exhaled air also contains 13C. This 13C-labeled carbon dioxide can be measured in specialized laboratories using a technique called "mass spectrometry". If after 30 minutes the breath sample contains more marked carbon dioxide (positive test), the patient may have H. pylori in the stomach or duodenum. If the exhaled air does not contain more marked carbon dioxide, the patient may not have H. pylori in the stomach or duodenum.
What studies have been performed on Pylobactell?
The data provided to support the use of Pylobactell come from two main studies on the use of antibiotics for the treatment of H. pylori infection, in which Pylobactell was used as a test. A total of 366 patients underwent the test with Pylobactell and a standard biopsy (a test in which a sample of tissue is taken from the stomach to look for a possible infection). The results obtained were compared to detect concordance.
What benefit has Pylobactell shown during the studies?
Pylobactell demonstrated a sensitivity greater than 95% in the detection of H. pylori infection .
What is the risk associated with Pylobactell?
There are no known side effects of the test.
Pylobactell should not be used in people who may be hypersensitive (allergic) to 13C urea or other tablet ingredients. The Pylobactell test should not be performed on patients with a confirmed or suspected gastric infection, which could interfere with the breathing test.
Why has Pylobactell been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell's benefits are greater than its risks for the in vivo diagnosis of H. pylori gastroduodenal infection and therefore recommended that it be given marketing authorization. product.
Other information on Pylobactell:
On 7 May 1998 the European Commission issued a marketing authorization for Pylobactell, valid throughout the European Union. The marketing authorization was renewed on 7 May 2003 and 7 May 2008. The marketing authorization holder is Torbet Laboratories Limited.
The full EPAR for Pylobactell can be found here.
Last update of this summary: 06-2008.
