Presence of symptoms referable to the proximal segment of the digestive system, indicative of a possible Helicobacter pylori infection. MedDRA version: 14.1 Level: LLT Classification code 10064777 Term: Helicobacter pylori urea breath test System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: BREATHQUALITY-UBT*OS FL 10ML
Pharmaceutical Form: Oral solution
INN or Proposed INN: 13C-UREA
CAS Number: 58069-82-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
AB ANALITICA SRL
Eligibility
Sex/Gender
All
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Comparative assessment of clinical data sensitivity and specificity of two 13C-urea breath test: BREATHQUALITY-UBT (AB ANALITICA Srl) and Helicobacter Test INFAI (INFAI GmbH) in the determination of gastro-duodenal infection by Helicobacter pylori and monitoring of eradication therapy.;Primary end point(s): Calculation of test sensitivity and specificity with shortened protocol (10 min) vs. the standard protocol (30 min) with reference to ''gold standard'' method to evaluate the H.pylori infection and to monitoring the eradication therapy.;Timepoint(s) of evaluation of this end point: 12 months;Main Objective: Diagnostic performance assessment of 13C-urea breath test BREATHQUALITY UBT (AB ANALITICA Srl) with a protocol of breath sampling after 10 minutes vs. the standard protocol with sampling after 30 minutes, compared to the reference method deemed ''gold standard ''(histology and urease test and / or bacterial culture). In patients infected with Helicobacter pylori, to evaluate the diagnostic efficacy, in terms of clinical sensitivity and specificity of urea breath test at carbon 13, with sampling after 10 minutes vs. standard sampling after 30 minutes in monitoring the success of eradication therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparative assessment of diagnostic performances of the test vs. another test authorized in the European Market (Helicobacter test INFAI);Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactDipart. Medicina Interna e Gastroen
PoliclinicoS.Orsola-Malpighi
Outcome results
None listed