Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tablet of 13C-Urea.

Phase 1

• Conditions: H. pylori infection; MedDRA version: 20.1Level: LLTClassification code 10019377Term: Helicobacter pylori infectionSystem Organ Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-001598-33-IT
• Lead Sponsor: SOFAR S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>Safety:<br>Adverse events will be recorded during the whole duration of the trial. ;Timepoint(s) of evaluation of this end point: Day 1