Helicobacter Pylori Clinical Trial
— HelicomatriOfficial title:
Prospective Randomized Trial: Comparison Between Optimized-dose Amoxicillin and Standard-dose Amoxicillin for Quadruple Therapy in the Treatment of Helicobacter Pylori Infection in Tunisian Patients
Verified date | October 2022 |
Source | Les Laboratoires des Médicaments Stériles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this prospective randomized clinical trial is to compare the rate of Helicobacter Pylori (HP) eradication after standard or dose-optimized amoxicillin quadritherapy in patients naïve to any anti-HP treatment and with chronic HP infection documented by histological examination. The main questions it aims to answer are: - compare the eradication rate of H.Pylori after a standard concomitant quadritherapy with 2g of amoxicillin versus an optimized quadritherapy with 3g of amoxicillin, in Tunisian population - Identify different factors associated with poor therapeutic response Patients were randomly assigned to either standard quadruple therapy (Qs-14: amoxicillin 1g twice daily, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days), or optimized quadruple therapy (Qo-14: amoxicillin 1g three times a day, clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40mg twice daily for 14 days). Eradication control was performed by urea breath test.
Status | Completed |
Enrollment | 88 |
Est. completion date | November 1, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - H. pylori infection documented by pathological examination of per endoscopic gastric biopsies. Exclusion Criteria: - Previously received H.Pylori eradication therapy. Known allergy to one of the components of the kit used (Helikit) for 13C-urea breath test (UBT). - A contraindication to 13C-UBT. Allergy or contraindication to the following antibiotics: Amoxicillin, Clarithromycin, Metronidazole and quinolones. - Received antibiotics during the four weeks, or proton pump inhibitors (PPIs) during the two weeks prior to inclusion in the study. - A history of bariatric surgery. Active gastro intestinal bleeding. - Severe comorbidity such as decompensated cirrhosis, end-stage renal disease, decompensated cardiac disease and neoplastic disease. - Patients on long-term immunosuppressive or corticosteroid therapy at a dose greater than 20mg/day. - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
Tunisia | Hepatogastroenterology department of Mahmoud Matri Hospital | Ariana |
Lead Sponsor | Collaborator |
---|---|
Les Laboratoires des Médicaments Stériles |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HP eeradication rate | Urea Breath test (UBT) is performed no sooner than 6 weeks after completion of H pylori therapy. Use of PPIs should be discontinued for at least 2 weeks before administration of the UBT. | 6 weeks after treatment completion | |
Secondary | prevalence of adverse reactions | The percentage of patients reporting side effects during treatment and the following days until the evaluation of Hp eradication | 6 weeks after treatment completion |
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