Evaluation of the impact of LacTEST on diagnostic thinking and on patient management, and of the reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.

Venter Pharma S.L.0 个研究点开始时间: 2015年6月1日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•1. Adults of either sex, between 18 and 70 years old.
•2. Capacity for understanding and giving the informed consent to participate in this study.
•3. Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the Gaxilose summary of product characteristics
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 144
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

•1. Pregnant women or breast-feeding women.
•2. Unable or reticent to give the informed consent or to comply with the study?s requirements.
•3. Severe renal insufficiency.
•4. Portal hypertension: ascites, cirrhosis.
•5. Medical records of total gastrectomy and/or vagotomy.
•6. Patients diagnosed with myxedema.
•7. Patients with Diabetes Mellitus.
•8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
•9. Patients who are drug abuse consumers.
•10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
•11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
•12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
•13. Patients with glomerular filtration rate (GFR) less 90 ml/min/1.73 m2.

发起方

Venter Pharma S.L.