Assessment of diagnostic performance of a Breath Test (BREATHQUALITY-UBT) to determinate the Helicobacter pylori infection and monitoring eradication therapy with a protocol shortened to 10 min by comparison with standard 30 min protocol and with another test authorized in the European market.

Conditions: Presence of symptoms referable to the proximal segment of the digestive system, indicative of a possible Helicobacter pylori infection.
MedDRA version: 14.1Level: LLTClassification code 10064777Term: Helicobacter pylori urea breath testSystem Organ Class: 10022891 - Investigations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2012-000064-24-IT

Lead Sponsor: AB ANALITICA SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1)presence of symptoms referable to the proximal segment of the digestive system (nausea, epigastralgy, retrosternal pyrosis, maldigestion, meteorism) 2)Patients with unknown H. pylori status 3)Patients aged 18 years. 4)Patients able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1) Patients who have had major abdominal surgery (appendectomy and colecystectomy are admitted). 2) Patients who are on chronic treatment with antisecretory drugs (4 months / years) and/or steroidal and non-steroidal anti-inflammatory drugs (1 week / month), 3) patients with disorders of the gastro-intestinal physiology (eg, Zollinger-Ellison syndrome) 4) Patients who received antisecretory drugs in the last 4 weeks, antibiotics or bismuth salts. 5) Patients already receiving eradication therapy vs. H. pylori. 6) Patients carrying coagulopathies and other conditions for which it is contraindicated to perform endoscopy and biopsy. 7) Severe renal failure 8) Pregnancy and lactation 9) Presence of ''alarm symptoms'' (melena, weight loss, anemia, haematemesis).