Daily Four Times or Two Times Usage of PPI and Amoxicillin for the First or Second Line H. Pylori Eradication
Ključne besede
Povzetek
Opis
This study aims to evaluate:
1. the first line H. pylori eradication rate of high dose dual therapy with 14 days rabeprazole 20 mg qid, plus amoxicillin 500 mg qid (HDDT group) comparing to the clarithromycin-based triple therapy with 14 days clarithromycin 500 mg bid, amoxicillin 1000mg bid , and rabeprazole 20mg bid (CATT group).
2. the eradication efficacy in rescue therapy of a levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 500 mg qid and rabeprazole 20 mg qid (LHDT group) comparing to the common levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 1000mg bid and rabeprazole 20 mg (LATT group).
Material and Methods Patients and study design This is a prospective, randomized, open-label trial. The patients diagnosed with H. pylori infection will be enrolled from Jan 2019 to Dec 2020 in Keelung Chang-Gung Memorial hospital. The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD). Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study. Patients without previous H. pylori eradication therapy are invited to receive the first-line regimens, whereas patients who have previously received H. pylori eradication therapy are invited to receive rescue regimens.
Hospital patients are asked to receive five endoscopic biopsy specimens (3 from gastric antrum and 2 from body mucosa) for rapid urease test (RUT) and culture studies. The definition of H. pylori infection is a positive finding from UBT, RUT or culture.
Diagnosis for H. pylori infection RUT Three specimens from endoscopic biopsy are used for the RUT (HelicotecUT ® plus test; Strong Biotech Corporation, Taipei, Taiwan). The test result will be read one hour later. A medium color change from yellowish to pink or red is recorded as a positive finding for H. pylori.
Bacterial culture and antibiotic susceptibility test Two specimens are homogenized and streaked onto an agar plate with selective medium. The plates are incubated at 37∘C under microaerophilic conditions (5% O2, 10% CO2, 85% N2) for 3-7 days. H pylori is identified by its characteristic biotyping. The primary isolates are subcultured for antibiotic susceptibility tests as described previously [21]. The E test strips (AB Biodisk, Solna, Sweden) are used for susceptibility testing. The resistance to antibiotics is according to MIC values of >0.5, ≥1, ≥8, and >1 mg/L for amoxicillin, clarithromycin, tetracycline, and levofloxacin, respectively [21].
Subjects should complete a standardized questionnaire and recorded symptoms and daily drug consumption during the treatment period to evaluate compliance and tolerability.
All patients are asked to describe any adverse event (diarrhea, taste disturbance, nausea ⁄ vomiting, bloating, abdominal pain, constipation, headache and skin rash) during the period when they are taking eradication drugs. The incidence of side effects is checked using a standardized degree of interference with daily activities format, as follows: absent; mild-not interfering; moderate-frequently interfering, but allowing treatment to be completed; severe-requiring interruption of treatment [33].
Four weeks after treatment completion, H pylori eradication success will be determined by 13C-UBT.
Datumi
Nazadnje preverjeno: | 12/31/2018 |
Prvič predloženo: | 01/09/2019 |
Predviden vpis oddan: | 01/10/2019 |
Prvič objavljeno: | 01/13/2019 |
Zadnja posodobitev oddana: | 01/10/2019 |
Zadnja posodobitev objavljena: | 01/13/2019 |
Dejanski datum začetka študija: | 01/01/2019 |
Predvideni datum primarnega zaključka: | 11/30/2020 |
Predvideni datum zaključka študije: | 11/30/2020 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Rabeprazole
Faza
Skupine rok
Roka | Intervencija / zdravljenje |
---|---|
Experimental: HDDT group high dose PPI induction (oral rabeprazole 20mg qid) for 3 days, then 14 days combined with amoxicillin (regular dose, daily 2 g, 500mg qid) for high frequency dual therapy. | |
Placebo Comparator: CATT group conventional triple therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid) | |
Experimental: LHDT group high dose PPI (oral rabeprazole 20mg qid) induction for 3 days, then Rabeprazole 20 mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd for 14 days. | |
Placebo Comparator: LATT group levofloxacin base rescue therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, levofloxacin 500 mg qd) |
Merila upravičenosti
Starost, primerna za študij | 20 Years Za 20 Years |
Spol, upravičen do študija | All |
Sprejema zdrave prostovoljce | Da |
Merila | Inclusion Criteria: - The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD). Exclusion Criteria: - Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study. |
Izid
Primarni izidni ukrepi
1. H. pylori eradication rate [2~3 months]