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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 a 13C‑Urea breath test kit designed for oral administration in pediatric patients aged 3 to 11 years. The kit contains the isotopically labeled 13C‑urea substrate used to detect Helicobacter pylori infection through a non‑invasive breath analysis. It is supplied as a single‑use kit and complies with European Union regulatory standards and meets quality control requirements for clinical use.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

The 13C‑Urea Breath Test Kit for children is primarily employed to identify active Helicobacter pylori infection in the gastrointestinal tract.

  • Detects current H. pylori colonization in children aged 3–11.
  • Supports clinical decision‑making for eradication therapy.
  • Provides a non‑invasive alternative to endoscopic biopsy.
  • Can be used to confirm successful eradication after treatment.
  • Suitable for screening in epidemiological studies involving pediatric populations.

Side Effects

Adverse events associated with the 13C‑Urea breath test are generally mild and related to the test procedure rather than the 13C‑Urea substrate itself.

Common

  • Temporary metallic taste in the mouth.
  • Mild nausea or abdominal discomfort.
  • Brief headache.
  • Slight increase in breath odor.

Serious

  • Allergic reaction such as rash or itching.
  • Severe respiratory distress (rare).

Precautions & Warnings

When using the 13C‑Urea breath test kit in children, several precautions should be observed to ensure accurate results and patient safety.

  • Verify the child’s age (3–11 years) before testing.
  • Ensure fasting as instructed, typically 2–4 hours prior to the test.
  • Discontinue proton pump inhibitors, antibiotics, and bismuth compounds for the recommended washout period.
  • Record any known allergies to urea or related compounds.
  • Use calibrated breath collection devices and follow the manufacturer’s timing protocol.
  • Avoid testing during acute gastrointestinal illness.
  • Document recent meals that may contain high urea content.

Avoid Interactions

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

Avoid

  • Proton pump inhibitors (e.g., omeprazole, esomeprazole) taken within 2 weeks of testing.
  • Antibiotics active against H. pylori within 4 weeks of testing.
  • Bismuth‑containing compounds within 2 weeks of testing.

Use with caution

  • Antacids taken on the day of the test (may affect gastric pH).
  • NSAIDs that cause gastric irritation (monitor for discomfort).
  • Herbal supplements containing urea or high protein (evaluate potential impact).

Frequently Asked Questions

The test uses isotopically labeled 13C‑urea, which Helicobacter pylori metabolizes into carbon dioxide; the labeled CO₂ is then measured in the exhaled breath to indicate infection.

After a fasting period, the child ingests a small dose of 13C‑urea solution, then breath samples are collected at baseline and after a set interval using a disposable collection device.

Children should fast for 2–4 hours, avoid proton pump inhibitors for at least two weeks, and discontinue antibiotics or bismuth compounds for the recommended washout period.

The breath test provides a non‑invasive alternative for detecting active H. pylori infection, but endoscopy may still be required for histology or when complications are suspected.

When performed according to protocol, the test has sensitivity and specificity above 90 % for identifying active infection in pediatric patients.

The test does not involve inhaled medications; however, any history of severe respiratory reactions should be discussed with a healthcare professional before testing.

A positive result indicates that Helicobacter pylori is present in the stomach and actively metabolizing the administered 13C‑urea.

Results are typically available within a few hours after the breath samples are analyzed in a laboratory equipped for isotope detection.

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

Mild nausea is a common, transient effect; offering water and allowing the child to rest usually resolves the symptom. Persistent discomfort should be reported to a clinician.

Besides fasting, children should avoid foods high in urea or protein that could affect baseline measurements, as advised by the testing protocol.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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