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Helicobacter Test For Children Of The Age 3-11

Active Ingredient:
13c-Urea
Origin:
EU

Helicobacter Test For Children Of The Age 3-11 (13c-Urea)

Helicobacter Test For Children Of The Age 3-11 is an in‑vitro diagnostic kit that uses the active ingredient 13C‑Urea to detect Helicobacter pylori infection. The test is supplied as a single‑use kit, intended for oral administration, and is marketed in the European Union. It is designed specifically for children aged three to eleven years and is available over the counter and can be performed in clinical or laboratory settings.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

The 13C‑Urea Breath Test Kit for children is indicated for the non‑invasive detection of Helicobacter pylori infection in pediatric patients.

  • Screening children with dyspeptic symptoms for H. pylori infection.
  • Confirming eradication after a prescribed treatment course.
  • Assessing infection status before initiating ulcer‑preventive therapy.
  • Supporting epidemiological studies of H. pylori prevalence in the 3‑11 age group.
  • Guiding clinicians in decision‑making for further gastrointestinal investigations.

Side Effects

The 13C‑Urea Breath Test is generally well tolerated, but some children may experience mild, transient reactions.

Common

  • Temporary metallic taste in the mouth after ingesting the labeled substrate.
  • Mild abdominal discomfort or bloating lasting less than an hour.
  • Slight increase in breath carbon dioxide levels detectable by the analyzer.
  • Brief nausea that resolves without intervention.
  • Transient headache reported by a small number of participants.

Serious

  • Allergic reaction such as rash, itching, or swelling of the face and throat.
  • Severe respiratory distress or wheezing indicating an anaphylactic response.
  • Persistent vomiting or diarrhea requiring medical evaluation.

Precautions & Warnings

When using the 13C‑Urea Breath Test in children, certain precautions help ensure accurate results and safety.

  • Ensure the child has fasted for at least 2 hours before the test to avoid food interference.
  • Verify that the child has not taken antibiotics, proton pump inhibitors, or bismuth compounds for at least 2 weeks prior.
  • Confirm the absence of known hypersensitivity to urea or any component of the test kit.
  • Use the kit only with the calibrated breath analyzer supplied by the manufacturer.
  • Record baseline breath samples before administering the 13C‑Urea substrate.
  • Avoid testing in children with severe respiratory conditions that may affect CO2 measurements.

Avoid Interactions

The 13C‑Urea Breath Test may be affected by certain medications or substances that alter gastric environment or urease activity.

Avoid

  • Recent use of antibiotics (e.g., amoxicillin, clarithromycin) that can suppress H. pylori.
  • Proton pump inhibitors, H2‑receptor antagonists, or bismuth‑containing compounds within 2 weeks before testing.
  • Antacids taken within 24 hours of the procedure.

Use with caution

  • Children receiving ongoing H. pylori eradication therapy should have the test postponed until therapy completion.
  • Use of corticosteroids or immunosuppressants may require interpretation of results in clinical context.
  • If the child has a metabolic disorder affecting carbon dioxide production, discuss result reliability with the clinician.

Frequently Asked Questions

The test is specifically validated for children between three and eleven years of age.

After oral ingestion of 13C‑Urea, H. pylori urease metabolizes it, releasing 13C‑CO2 that is measured in the child’s exhaled breath.

Yes, a minimum of two hours of fasting is recommended to avoid food interference with the breath sample.

Antibiotics taken within the past two weeks can suppress H. pylori and may lead to false‑negative results.

The kit is classified as over‑the‑counter (OTC) and can be purchased without a prescription in the EU.

A rash may indicate an allergic reaction; discontinue use and seek medical evaluation promptly.

Results are typically available within 30 minutes after the post‑dose breath sample is analyzed.

No, PPIs should be stopped at least two weeks before the test to avoid false‑negative outcomes.

Children with severe respiratory disorders may have altered CO2 measurements; consult a clinician before testing.

The baseline sample establishes the natural 13C/12C ratio, allowing accurate comparison after the 13C‑Urea dose.

Yes, a follow‑up breath test performed at least four weeks after therapy can confirm eradication.

The kit should be stored at room temperature, protected from moisture and direct sunlight, and used before the expiration date.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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