Health regulators at the FDA have approved Otsuka America Pharmaceutical’s BreathTek UBT test to detect Helicobacter pylori (H.pylori) bacterial infection that causes stomach inflammation and ulcer, for use in children aged 3 to 17 years. The test has been used for adults since 1996.
According to the CDC, nearly two-thirds of the world’s population is infected with H. pylori, never have any symptoms. However, those who do harbor the bactria “have a two- to six-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type lymphoma compared with uninfected people,” the agency reported.
When symptoms do occur they usually include loss of appetite, weight loss, bloating, excessive burping, nausea and vomit resembling coffee grounds as well as bloody vomit. In addition, bowel movements may tend to be black and “tarry.”
“Results from the BreathTek UBT test can quickly indicate infection (when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines), which allows a doctors to initiate appropriate health measures in a timely manner,” commented 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 test for children on a multi-center study of 176 patients, comparing its performance to a composite reference method and demonstrating “95.8% percent sensitivity and 99.2% specificity.” A further study was done at 1 to 6 months after therapy to support use for post-treatment monitoring of patients. Results of the follow-up showed the sensitivity was “83.3% and the specificity was 100%.”
Once diagnosed, H. pylori infections are usually treated with two varieties of antibiotics at once, to help prevent the bacteria from developing a resistance to one particular antibiotic. In addition, physicians may also prescribe an acid suppression drug, to help heal the stomach lining.
For more information consult your family doctor.