10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication
10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the
 half population in the world. Colonization of this bacteria is suspected to be one of the
 main risk factor for the occurrence of various abnormalities of the upper gastrointestinal
 tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple
 therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The
 recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple
 therapy with longer duration will provide a higher percentage of eradication. This study
 wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter
 pylori eradication.
This is a double-blinded randomized clinical trials, to determine the proportion of
 eradication of Helicobacter pylori infection using a triple therapy regimen for 10 days and
 14 days. The triple therapy regimen was a proton pump inhibitor (Rabeprazole 20 mg twice
 daily), Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.

 Patients with dyspepsia and no improvement for at least 2 weeks with empiric therapy
 (lifestyle education, antacid, H2-antagonist, or proton pump inhibitor), are further
 investigated to determine the presence of Helicobacter pylori infection using invasive
 (Esophagoduodenoscopy/EGD) or non-invasive methods (Urea Breath Test/UBT).

 Patients with positive results on UBT or histology examination from EGD and fulfill inclusion
 and exclusion criteria are included as research subjects, then randomly assigned to determine
 the subject of the study into the sample of study entry in group 1 or group 2.

 All subjects will be required to fill out informed consent, demographic data, anthropometric
 measurements, and questionnaires.

 Research subjects will get triple therapy regimen for Helicobacter pylori infection in the
 form of Proton Pump Inhibitor (Rabeprazole 2 x 20 mg), Amoxicillin 2 x 1000 mg, and
 Clarithromycin 2 x 500 mg.

 Pharmacy will create two sets of regimens, in which one group of regimens contains triple
 therapy regimens for 10 days followed by the same regimen for 4 days, while another regimen
 group contains triple therapy regimens for 10 days Day followed by placebo for 4 days.
 Neither the researcher nor the study subjects knew the triple therapy regimen given to group
 1 and group 2 subjects, and only became known after the end of the study.

 All subjects will be monitored given drug consumption and evaluated regularity, complaints,
 and adverse effects arising for 14 days by researchers. The patient is given a control card
 to write down medication time and any possible complaints or side effects of drug allergic
 reactions, epigastric pain, headache, discomfort, and nausea / vomiting, and other side
 effects will be observed during the study. The patient will be determined whether the study
 will continue or not.

 After the therapy was completed, the subjects of the study will be re-examined as an
 evaluation of eradication success, at least 28 days after completion of triple therapy
 regimen.

 If UBT negative results obtained at the time of evaluation, the eradication is success, when
 positive UBT results are obtained at the time of evaluation, eradication is failed and the
 subjects are persistent with first-line therapy.

 Persistent patients are encouraged to undergo an EGD at Cipto Mangunkusumo Hospital for the
 culture of Helicobacter pylori infection resistance. If the patient is not willing to be
 underwent EGD, then the patient is given second-line treatment regimen of Levofloxacin 2 x
 500 mg, Amoxicillin 2 x 1000 mg, and Rabeprazole 2 x 20mg.
Inclusion Criteria:

 -  18 years or older patients who are proven to be infected by Helicobacter pylori based
 on positive in Urea Breath Test or positive in histopathologic examination of biopsy
 in antrum and corpus of gaster through esophagoduodenoscopy.

 Exclusion Criteria:

 -  Patients refuse to follow the research

 -  Patient has had previous eradication therapy of Helicobacter pylori infection.

 -  The patient is pregnant or breastfeeding

 -  Patients have a history of allergy to one component of triple therapy regimen (proton
 pump inhibitor, penicillin, and / or macrolide) before.

 -  Patients are known to have impaired liver function, evidenced by ALT values within
 normal limits, and no previous liver disease.

 -  Patients were found to have arrhythmias or obtained QT wave elongation on
 electrocardiographic