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New Test To Detect H.Pylri Infection in Children

New Test To Detect H.Pylri Infection in Children

(ePharmaNews) – FDA approved the use of breath test in children to detect the bug that causes peptic ulcer disease. The test will be the first to be used in children aged between 13 and17, though it has been used since 1996 to detect the same germ, Helicobacter.pylori, in adults.


The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world’s population is infected with H. pylori. Most people with this infection never have any symptoms but have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people.
“Results from this test, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can quickly indicate infection, which allows a physician to initiate appropriate health measures in a timely manner,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health.
The FDA based its approval of the breath test for children on a multi-center study of 176 patients, comparing its performance to a standard method and demonstrating 95.8 percent sensitivity and 99.2 percent specificity. Moreover, other studies were done to prove efficiency in confirming eradication after treatment.
H.Pylori, the most widespread infection among humans, was discovered in 1982 by Australian scientists; Barry Marshall and Robin Warren in the stomach of patients having peptic ulcers and chronic inflammation. The discovery led to Nobel prize in 2005.
The bacterium is a helix-shaped that lives in the stomach mucosa. Several test are used to detect H.pylori, some of them depend on serum, feces or even direct visualization in a tissue extracted by endoscope. Breath test is the most feasible one, since it can take only few minutes and does not bother the patient. The test depends on the fact that H.pylori breakdown urea and release CO2, which can be measured in the breath to determine the infection.
Why Children?
Several studies have pointed out that people acquire H.pylori infection in the childhood, and supposed that early treatment can prevent from the complications, furthermore, in one study that is going to be published next month, scientists are investigating whether treated children grow up faster than non-treated peers.

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Prepared by: Laila Nour

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