Optimization of Second Line Treatment Protocol for H Pylori Eradication
Conditions
Keywords
sequential therapy, second line treatment, H pylori
Brief summary
The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .
Detailed description
a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up. Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group. The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication. Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects. Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .
Interventions
DRUGLansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication
DRUGLansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
this combination is standard of care as H pylori second line treatment
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. signed informed consent 2. age at least 18 years 3. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)
Exclusion criteria
1. history of gastrectomy 2. gastric malignancy, including adenocarcinoma and lymphoma 3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors 4. Active upper gastrointestinal bleeding within the previous 1 week 5. contraindications to the treatment drugs 6. Pregnant or lactating women 7. Severe concurrent disease or malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen | 18 month | H pylori eradication is defined as a negative C-urea breath test 4-16 weeks after completion of tratment.\]. (C-urea breath test- Patients are fasted for 4 h before testing. No test meal will be given, and a pre-dose breath sample is obtained. 75 mg of 13C-urea powder dissolved in 50 mL of water is then administered orally, and a second breath sample is collected 30 minutes later. Collected samples are analyzed using an isotope ratio mass spectrometer). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary end points: Adverse effects of sequential and quadruple treatment | 18 months | -Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question. |
| compliance with treatment | 18 months | compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count). |
Countries
Israel
Outcome results
None listed