Helicobacter pylori infection is prevalent in North America (33%), especially among African Americans (52%), Hispanic Americans (64%), and immigrants from countries with widespread infection (eg, Korea [60%], Japan [39%]).1-3 It is typically acquired during childhood and, in adults and children, plays a causative role in diseases such as ulcers (eg, duodenal, gastric), uninvestigated dyspepsia, and gastritis (eg, chronic active, persistent, atrophic).1,2,4 Additionally, H pylori infection has been identified as an independent risk factor in 70% of gastric cancer and 90% of mucosa-associated lymphoid tissue (MALT) lymphoma cases.5,6

Helicobacter pylori infection usually responds well to a 3- to 14-day multidrug regimen, which may include first-line therapies such as clarithromycin-based triple therapy or bismuth-based quadruple therapy.1,*

Effective treatment depends on accurate diagnosis and post-treatment testing for the eradication of H pylori. Consideration may be given to current guidelines which recommend diagnostic and post-treatment testing using either a 13C-urea breath test (UBT) or stool antigen test.1,7,8

Diagnostic Testing

• Patients with symptomatic peptic ulcer disease, history of gastroduodenal ulcers, or MALT lymphoma
• Patients with uninvestigated dyspepsia

Post-treatment Testing

• Patients with a diagnosis of H pylori infection and ≥4 weeks post-treatment

Laboratory tests are available to help in the diagnostic workup of H pylori infection, and assess post-treatment eradication. They can be categorized as endoscopic or nonendoscopic.9 Rapid urease test (RUT) and histologic examination are assays available to help diagnose H pylori infection in upper gastrointestinal (GI) tract endoscopic biopsy specimens.7 UBT and stool antigen tests are nonendoscopic, noninvasive assays available as aids in the diagnosis and post-treatment monitoring of H pylori infection in adults and pediatric patients (Table).

Tests for Diagnosing

Test selection for diagnosing H pylori infection can depend on the patient's clinical condition and the physician's preferred strategy for diagnosis. Testing for H pylori should only be performed if the clinician plans to offer treatment for positive results as infection is rarely self-limiting.1

Patients With Symptomatic Peptic Ulcers, History of Gastroduodenal Ulcers, or MALT Lymphoma

Endoscopic biopsy or noninvasive tests such as UBT or the stool antigen test can help diagnose H pylori infection. Note that UBT has not been cleared by the FDA for use in individuals under 3 years of age.10 Examination of biopsy specimens by culture can be useful for determining infection status and antibiotic sensitivity. However, it is expensive and not widely available.12

Positive results on biopsy or from UBT or the stool antigen test indicate infection. Guidelines recommend that patients with positive results be offered H pylori eradication therapy.1,7 Negative results do not necessarily rule out infection and should be confirmed with additional testing, especially in the presence of acute upper GI bleeding.9

Patients With Uninvestigated Dyspepsia

Endoscopic biopsy and nonendoscopic tests, such as UBT and the stool antigen test, can also help diagnose H pylori infection in patients with uninvestigated dyspepsia. Patient age and the presence of alarm features can help guide the diagnostic workup of suspected H pylori infection.

Patients >55 Years of Age or With Alarm Features

Patients with uninvestigated dyspepsia who 1) are >55 years of age or 2) younger but have alarm features should be promptly tested with RUT or histologic examination of upper GI tract biopsy specimens.7 Alarm features include anemia, gastrointestinal bleeding, family history of gastrointestinal cancer, early satiety, unintended weight loss of >10%, history of esophagogastric malignancy, previous documented peptic ulcer, progressive dysphagia, odynophagia, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.7,8 Positive results on biopsy indicate infection, and guidelines recommend offering H pylori eradication therapy to patients with positive results.1,7 Negative results should be confirmed with additional testing such as UBT or the stool antigen test; false negative results may be increased in the setting of acute GI bleeding.9

Patients ≤ 55 Years of Age Without Alarm Features

Although current guidelines differ somewhat, 2 main strategies are used to diagnose H pylori infection in patients with uninvestigated dyspepsia who are ≤ 55 years of age without alarm features.1,7,8

For the test first (test-and-treat) strategy, patients are first tested with a noninvasive assay for H pylori infection. Positive results from UBT or the stool antigen test indicate the need for treatment to eradicate H pylori, followed by a trial of acid suppression if symptoms persist after successful eradication. Negative results on noninvasive assays are followed by a 4- to 8-week empirical trial of acid suppression therapy with a proton pump inhibitor (PPI). This strategy may be most beneficial in populations with a moderate-to-high prevalence of H pylori infection, defined as >10% in some guidelines.1,8

For the treat first (empiric) strategy, patients are first treated with a 4- to 8-week empirical trial of acid-suppressing therapy with a PPI.1,7 If the PPI trial fails or the patient relapses after the end of treatment, the test-and-treat strategy should be pursued before contemplating endoscopy.1,7 Empirical treatment can be used in populations with a low prevalence of H pylori infection, defined as ≤10% in some guidelines.1,7

Post-treatment Testing

Treatment success should be assessed by follow-up testing with a noninvasive assay such as UBT test, stool antigen test, or upper GI tract endoscopic biopsy if endoscopy is indicated.1 UBT and antigen-based testing should be performed at least 4 weeks after treatment.1,12 This approach allows any remaining H pylori to recover and repopulate the stomach in sufficient numbers to be detected reliably.13 Detection of H pylori following eradication therapy indicates recurrence or ineffective treatment. Examination of endoscopic biopsy by culture may help assess H pylori antibiotic susceptibility in persistent infection but is limited by sample viability (ie, refrigeration up to 48 hours or frozen in broth at -70℃ up to 5 days).1

* The treating healthcare professional should refer to the manufacturer's approved labeling for prescribing, warnings, side effects and other important information relating to treatment options.

This information is provided for informational purposes only and is not intended as medical advice. A physician's test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.