Urea Breath Test for Detecting H. pylori

What is H. pylori Infection?

Helicobacter pylori (H. pylori) organisms are spiral-shaped, gram-negative bacteria that cause peptic ulcers. The bacteria can buffer stomach acid by breaking down urea to ammonia and carbon dioxide. It is thought that ammonia can neutralize gastric hydrochloric acid. H. pylori infection will eventually irritate and destroy the stomach lining leading to a painful peptic ulcer.

What is the principle of the Urea Breath Test?

The diagnostic drug component of the BreatkTek urea breath test kit is ¹³C-urea contained in a granulated power (Pranactin^®-Citric). Each three (3) gram dose of Pranactin-Citric contains 75 mg ¹³C-urea, citric acid, aspartame and mannitol. The Pranactin-Citric powder is mixed with potable water for oral ingestion by the patient. A baseline breath sample and a 15-minute Post-Dose breath sample are collected into breath bags.

In the presence of H. pylori organism, urea is converted by the bacterial enzyme urease to ¹³CO₂ and ammonia. The ¹³CO₂ is absorbed in the blood and then exhaled in the breath. This results in an increase in the ratio of ¹³CO₂ to ¹²CO₂ in expired breath in the Post-Dose breath sample. In the absence of H. pylori, the Post-Dose breath sample has essentially the same amount of ¹³CO₂ as the baseline breath.

What causes Peptic Ulcers?

H. pylori organisms colonize in the stomach. The colonization induces production of inflammatory cytokines that causes gastric inflammation. The inflammatory response consists of polymorphonuclear and mononuclear cells. Eventually, chronic gastritis and ulceration will develop if the infection is left untreated.

H. pylori infection and its association with gastric malignancy has been published in multiple epidemiological studies. The proposed stepwise progression to gastric malignancy is H. pylori infection to chronic gastritis, to atrophic gastritis, intestinal metaplasia, and finally to gastric cancer. More than 500,000 new cases of stomach cancer every year are attributed to H. pylori.

Why should I test for H. pylori Infection with the Urea Breath Test?

Many healthcare professionals are now aware of the importance of testing for H. pylori and treating H. pyori infection. Unfortunately, physicians sometimes fail to order follow-up testing to prove H. pylori eradication after a course of antimicrobial therapy.

The Urea Breath Test offers many advantages over other H. pylori tests for initial diagnosis and follow-up testing. As a healthcare provider you can be comfortable knowing that your choice to use the Urea Breath Test means that you are offering your patient the best possible care. The advantages include:

Testing for Active H. pylori infection avoids unnecessary treatment

• Empiric therapy with antibiotics does not confirm infection and can contribute to antibiotic resistance
• Serology cannot distinguish between active and recent infection and is 18 times more likely to lead to unnecessary treatment⁽¹⁾

Best test for confirmation of cure

• FDA cleared to confirm cure
• Offers doctor and patient peace of mind by ensuring that infection has been eradicated
• Allows for a follow-up visit for optimized patient management

Superior performance characteristics compared to other H. pylori tests

Urea Breath Test (BreathTek^TM) compared to other H. pylori tests

• Active or antibody testing to diagnose H. pylori infection? Examining the clinical and economic tradeoffs using decision analysis (abstract). Gastroenterology. 2000;118, No. 4, Suppl. 2: A2699.
• Data on file.
• Graham KS, Graham DY. Contemporary Diagnosis and Management of H. Pylori-Associated Gastrointestinal Diseases. Newtown, PA: Handbooks in Health Care Co; 2002.
• Medical Device Agency Evaluation Report, number MDA/97/55.
• PYtest package insert. Tri-Med Specialties Inc.
• Vaira D, Vakil N. Blood, urine, stool, breath, money, and Helicobacter pylori. Gut. 2001;48:287-289.

What types of patients get H. pylori infections?

An estimated 35% of the entire adult US population is infected with H. pylori. In the United States, for people younger than 30 years, estimated prevalence is 20%, and for people older than 60 years, estimated prevalence is 50%. Infection in very young children is rare.

Higher prevalence rates are noted among blacks, Hispanics, Asians, and American Indians. Infection rates are similar in males and females.

What are the symptoms of Peptic Ulcer Disease?

The initial sign of peptic ulcer disease is an upset stomach. The epigastric pain is often described as burning or gnawing that goes through to the back. Pain comes several hours after a meal when the stomach is empty and is often worse at night. The epigastric pain lasts from a few minutes to several hours. Epigastric pain may be relieved by food, antacids or vomiting.

Other symptoms of a peptic ulcer include:

• Nausea
• Vomiting
• Gas (burping)
• Abdominal bloating
• Appetite loss

How do I treat H. pylori Infection?

When H. pylori infection is identified, the most widely used front-line therapy consists of 7 to 14 days of a proton pump inhibitor, clarithromycin and amoxicillin. Metronidazole may be used as an alternative to amoxicillin, particularly in the setting of a penicillin allergy or intolerance. This therapy eliminates the bacteria and prevents recurrence of ulcers in 75 to 80% of people who receive the treatment. Unfortunately, side effects of this treatment are common. Several new antibiotic alternatives exist that require less treatment time and simpler treatment regimens.

Metabolic Solutions is a licensed provider of the Meretek Diagnostics group of Otsuka America Pharmaceutical, Inc. BreathTek^TM UBT. The BreathTek^TM UBT and Pranactin-Citric^TM are trademarks of Meretek Diagnostics group of Otsuka America Pharmaceutical.