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

SOFAR S.P.A.0 sites46 target enrollmentJanuary 18, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 18, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

SOFAR S.P.A.

•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

•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;