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Clinical Trials/EUCTR2012-000064-24-IT
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.

Registry
who.int
Start Date
July 23, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AB ANALITICA SR

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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