H. pylori infection MedDRA version: 20.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: EXPIROBACTER - 100 MG COMPRESSA SOLUBILE 1 COMPRESSA
Product Name: EXPIROBACTER 100 mg compressa solubile
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: UREA 13 C
CAS Number: 5
Sponsors
SOFAR S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both sexes. 2. Age = 18 years old 3. Outpatients, for whom urea breath test for H. pylori infection is indicated. 4. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Therapy with antibiotics or bismuth in the 4 weeks before the enrollment; 2. Therapy with inhibitors of the proton pump in the 2 weeks before the enrollment; 3. Presence of alarm symptoms (e.g. unintentional weight loss, sideropenic anemia, gastrointestinal bleeding, dysphagia); 4. Atrophic gastritis; 5. Gastro-enteric tract neoplasia; 6. Known or suspected hypersensitivity to one or more components of EXPIROBACTER®; 7. Pregnancy or lactation; 8. Recent or suspected alcohol or drug abuse; 9. Presence of any kind of dementia or other possible causes of a progressive deterioration of the full possession of one's faculties or a psycho-physic inability that decreases the ability to take correctly the prescribed treatment; 10. Not sufficiently reliable or presence of conditions that may result in non-compliance/adherence of the patient to the protocol; 11. Concomitant involvement in another clinical trial; 12. Minor patients; 13. Patients who are unable to carry out study procedures or who have not given their written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Concordance between the results obtained with the two methods;Secondary Objective: Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry.;Primary end point(s): Concordance of the results given with the molecular correlation spectrometry method (Breath ID®) and with the infrared spectrometry, for the diagnosis of H. pylori infection;Timepoint(s) of evaluation of this end point: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry. Safety: Adverse events will be recorded during the whole duration of the trial. ;Timepoint(s) of evaluation of this end point: Day 1 | — |
Countries
Italy
Contacts
Public ContactDivisione Medica
SOFAR S.p.A.
Outcome results
None listed