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 个研究点目标入组 46 人开始时间: 2018年1月18日最近更新: 2018年1月29日

试验速览

暂无简介。

•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;
•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.

发起方

SOFAR S.P.A.