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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)

The Helicobacter Test for Children of the Age 3‑11, formulated with the isotopic marker 13C‑Urea, is an oral diagnostic assay designed to detect Helicobacter pylori infection in pediatric patients. Produced for European market, the test utilizes a breath‑test principle and is intended for use with supervision. It does not contain therapeutic medication and is approved for clinical use in children aged three to eleven years.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

Helicobacter Test for Children aged 3‑11 is used as a diagnostic tool to identify active Helicobacter pylori infection in pediatric patients.

  • Detects H. pylori infection via 13C‑urea breath test in children 3–11 years old.
  • Supports clinical decision‑making for treatment initiation.
  • Provides a non‑invasive alternative to endoscopic sampling.
  • Can be used to confirm eradication after therapy.
  • Suitable for screening in epidemiological studies involving school‑aged children.

Side Effects

The test may be associated with transient, generally mild reactions related to the test procedure or the urea substrate.

Common

  • Temporary metallic taste in the mouth.
  • Mild nausea or stomach discomfort.
  • Brief headache or dizziness.
  • Slight increase in breath odor due to labeled carbon dioxide.

Serious

  • Allergic reaction such as rash, itching, or swelling.
  • Severe respiratory distress or anaphylaxis (very rare).
  • Persistent vomiting or abdominal pain requiring medical attention.

Precautions & Warnings

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

  • Verify the child is between 3 and 11 years of age before testing.
  • Ensure the child has fasted according to the test protocol (usually 2‑4 hours).
  • Review medical history for known urea allergy or severe metabolic disorders.
  • Inform the clinician of any recent antibiotic, proton‑pump inhibitor, or bismuth use, as these may affect results.
  • Use the test only under qualified healthcare supervision.
  • Store the kit at room temperature, protected from moisture.

Avoid Interactions

Certain medications or substances can interfere with the accuracy of the 13C‑urea breath test or increase the risk of adverse reactions.

Avoid

  • Recent use (within 2 weeks) of antibiotics active against H. pylori.
  • Proton‑pump inhibitors or H2‑receptor antagonists taken within 2 weeks.
  • Bismuth‑containing compounds within 4 weeks.
  • High‑dose vitamin C supplements taken on the day of testing (may affect breath results).

Use with caution

  • Antacids taken on the day of testing (may modestly alter gastric pH).
  • Herbal remedies that affect gastric acidity, such as licorice root.

Frequently Asked Questions

The test uses a 13C‑Urea breath technique: the child ingests a small amount of 13C‑labelled urea, and if Helicobacter pylori is present, the bacteria break down the urea, releasing 13C‑labelled carbon dioxide that is measured in the exhaled breath.

A calibrated oral dose of 13C‑Urea is given as a flavored liquid or tablet that the child swallows under supervision, followed by a short waiting period before breath collection.

Children should fast for 2‑4 hours, avoid dairy and high‑fiber foods, and refrain from antibiotics, proton‑pump inhibitors, H2 blockers, or bismuth compounds for the recommended wash‑out periods.

Breath samples are analyzed in a laboratory or point‑of‑care device, and results are typically available within 30 to 60 minutes after collection.

Yes, the 13C‑Urea breath test is commonly employed 4‑6 weeks after completing H. pylori therapy to verify that the infection has been cleared.

The test is generally safe for children with asthma, but clinicians should assess individual risk and ensure the child can perform the breath collection without distress.

Most children experience only mild, transient effects such as a metallic taste, slight nausea, brief headache, or a temporary change in breath odor.

Antibiotics that target H. pylori can suppress bacterial activity, leading to false‑negative results; therefore a wash‑out period of at least two weeks is recommended.

The test is supplied through licensed medical laboratories, hospitals, and authorized diagnostic distributors operating within the European Union.

In most EU countries the test is ordered by a qualified healthcare professional and is not available over the counter.

After the waiting period, the child exhales into a disposable collection bag or a specialized breath‑capture device, which is then sealed and sent for analysis.

Clinical studies report sensitivity and specificity rates above 90 % for the 13C‑Urea breath test in pediatric populations when proper preparation is followed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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