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 个研究点开始时间: 2012年7月23日最近更新: 2014年6月2日

试验速览

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•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

•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).

发起方

AB ANALITICA SR