EUCTR2012-000064-24-IT
Active, Not Recruiting
N/A
Comparative assessment of diagnostic performance of C13-Urea Breath Test (BREATHQUALITY-UBT, oral solution C13-Urea 75 mg/10 mL) with 10 min protocol vs standard 30 min protocol to determinate the Helicobacter pylori infection in patients with upper gastrointestinal symptoms and in monitoring eradication therapy.
AB ANALITICA SR0 sitesJuly 23, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AB ANALITICA SR
- Status
- Active, Not Recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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