High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The investigators will performed a large-scale multi center trial to compare the efficacy of
a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300)
patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and
Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to
symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80
years old will be excluded. All patients will be naive to eradication therapy and will be
randomized into one of three groups:
Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg
and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin
500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).
All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim
of the study is to assess eradication success, intentioned to treat and per protocol in the
three treatment regimens.
The secondary aim of the study is to assess the safety of high dose amoxicillin and
doxycycline.