Gastritis H Pylori
Conditions
Keywords
Breath Tests, Helicobacter pylori
Brief summary
In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.
Detailed description
This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist. The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.
Interventions
DRUGmetronidazole based quadriple therapy
patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)
DRUGplacebo based quadriple therapy
patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.
Sponsors
mohamed bouchoucha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
a placebo which has the same visual characteristics as metronidazole in the boxes of the triple therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 18 and 65, with documented Hp infection.
Exclusion criteria
are excluded patients: * With Cirrhosis. * With Renal failure (serum creatinine\> 120 µmol / L). * Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase. * Having severe psychiatric disorders. * Having had gastric surgery in their history. * Having already received an HP eradication treatment. * Having received an antibiotic within the last two weeks. * Who are allergic to one of the antibiotics used in the anti-Hp cure. * Who are drug addicted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HP eradiction rate | 6 weeks after completion of study treatment | assessment by breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of adverse reactions | 3 months | we will determinate the percentage of adverse reactions in each group of treatment. |
Countries
Tunisia
Outcome results
None listed