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Helicobacter Test

Active Ingredient:
13c-Urea
Origin:
EU

Helicobacter Test (13c-Urea)

Helicobacter Test is a diagnostic product that contains the 13C‑Urea isotope as its active ingredient. It is supplied for oral administration and is used in the European market to detect infection with Helicobacter pylori. The test is performed by having the patient ingest the 13C‑Urea, after which exhaled breath is analyzed for labeled carbon dioxide, indicating bacterial urease activity. Results are available within a few hours, aiding clinicians.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

Helicobacter Test is employed as a non‑invasive diagnostic tool for detecting active Helicobacter pylori infection.

  • Screening of adults presenting with dyspeptic or upper‑GI symptoms to identify active H. pylori infection.
  • Confirmation of bacterial eradication after a prescribed course of antibiotics, typically performed 4‑6 weeks post‑treatment.
  • Evaluation of population prevalence in epidemiological surveys, providing a reliable, non‑invasive measure of infection rates.
  • Assessment of H. pylori status before endoscopic procedures or gastric surgery to guide peri‑operative management.
  • Use in cases where serologic testing is ambiguous or where patients have received recent antibiotics or proton‑pump inhibitors.

Side Effects

Helicobacter Test is generally well tolerated, but as with any diagnostic agent, some individuals may experience mild or, rarely, more serious reactions. These events are usually self‑limiting and do not require specific treatment.

Common

  • Mild nausea or stomach upset after ingesting the urea solution.
  • Temporary abdominal bloating or mild cramping.
  • Brief metallic or unusual taste sensation during the test.
  • Light‑headedness or mild headache that resolves quickly.
  • Mild transient dizziness or feeling of warmth.

Serious

  • Allergic reaction such as rash, itching, swelling of the face or throat.
  • Severe vomiting or persistent gastrointestinal distress.
  • Anaphylactic shock, though extremely rare, requiring immediate medical attention.
  • Severe abdominal pain with signs of intestinal obstruction (very rare).

Precautions & Warnings

When using Helicobacter Test, certain precautions should be observed to ensure accurate results and patient safety.

  • Patients should fast for at least one hour before ingesting the 13C‑Urea solution to avoid dilution of the breath sample.
  • Recent use of antibiotics, bismuth compounds, or proton‑pump inhibitors may suppress bacterial urease activity and lead to false‑negative results; a washout period is recommended.
  • Individuals with known hypersensitivity to urea or related compounds should avoid the test.
  • Pregnant or lactating women should discuss the test with their healthcare provider, as safety data are limited.
  • Children under the age of six may require alternative diagnostic methods due to limited data on test performance.

Avoid Interactions

Helicobacter Test may interact with certain medications or substances that affect gastric environment or urease activity, potentially altering test accuracy.

Avoid

  • Antibiotics (e.g., clarithromycin, amoxicillin, metronidazole) taken within the previous 2‑4 weeks.
  • Bismuth‑containing compounds used within the past 2 weeks.
  • Proton‑pump inhibitors (omeprazole, esomeprazole, lansoprazole) taken within the previous 2 weeks.

Use with caution

  • H2‑receptor antagonists (cimetidine, ranitidine) – may require a longer washout period.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) – can cause gastric irritation that may affect results.
  • Herbal supplements that influence gastric acidity (e.g., antacids, ginger) – advise temporary discontinuation.
  • Alcohol consumption on the day of testing – may affect breath sample composition.

Frequently Asked Questions

The test relies on the ability of Helicobacter pylori urease to split ingested 13C‑Urea into carbon dioxide and ammonia; the labeled 13C‑CO2 is then measured in the patient’s exhaled breath.

The patient drinks a solution containing 13C‑Urea, waits a short period (usually 30 minutes), then provides breath samples that are analyzed for the presence of 13C‑labeled carbon dioxide.

Adults with dyspeptic symptoms, those being evaluated for H. pylori eradication after therapy, and individuals requiring confirmation of infection before endoscopic procedures are typical candidates.

Laboratory analysis of the breath sample usually takes a few hours; many clinics provide results on the same day or within 24 hours.

Yes, antibiotics can suppress H. pylori activity and may produce false‑negative results; a washout period of at least two weeks is commonly recommended.

Safety data are limited; pregnant or lactating women should discuss the test with their healthcare provider before proceeding.

Mild nausea, temporary abdominal discomfort, a metallic taste, or brief dizziness are the most frequently reported mild reactions.

Patients should fast for at least one hour, avoid antibiotics, bismuth, and proton‑pump inhibitors for the recommended washout period, and disclose any known urea hypersensitivity.

The breath test detects active bacterial urease activity, indicating current infection, whereas serology measures antibodies that may remain positive after the infection has been cleared.

The test should be stopped immediately, and the patient should receive appropriate medical treatment, including antihistamines or epinephrine if anaphylaxis is suspected.

Yes, PPIs can reduce gastric acidity and bacterial activity, potentially leading to false‑negative results; they should be discontinued for at least two weeks before testing.

The test is validated for older children and adolescents; for children under six years of age, alternative diagnostic methods are often preferred.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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