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Completed

NCT Number: NCT05635942

Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hepatogastroenterology department of Mahmoud Matri Hospital

Aryanah, 2080, Tunisia

About this study

This study was a prospective, randomized, single-center study conducted in the hepato-gastroenterology department of Mahmoud Matri Hospital in Ariana, in collaboration with the bacteriology and biochemistry laboratory of the same hospital, the anatomopathology department of Abderrahmen Mami Hospital in Ariana, and the private clinical analysis laboratory "Fendri". all patients aged from 18 and 65 years-old with H. pylori infection documented by pathological examination of per endoscopic gastric biopsies were recruited.

This was a population of patients who had undergone upper endoscopy (UE) and in whom the search for H.Pylori was indicated, according to the European Maastrich IV recommendations.

Eligible subjects were randomly assigned in a 1:1 ratio to receive either standard quadruple therapy (Qs-14) including : amoxicillin 1g twice daily ,clarithromycin 500mg twice daily ,metronidazole 500mg twice daily and esomeprazole (Medis Pharmaceutical Company) 40 mg twice daily for 14 days, or optimized quadruple therapy (Qo-14) including : amoxicillin 1g three times daily ,clarithromycin 500mg twice daily, metronidazole 500mg twice daily and esomeprazole 40 mg twice daily (Medis Pharmaceutical Company) for 14 days.

Eradication control was performed by 13C-UBT at least 4 weeks after the end of the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

optimized quadruple therapy

Drug

Association of amoxicillin 3 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days

Other names: Qo-14

standard quadruple therapy

Drug

Association of amoxicillin 2 g/day + Esomeprazole, nitroimidazole and clarithromycin for 14 days

Other names: Qs-14

Primary outcomes

  1. HP eeradication rate

    Time frame: 6 weeks after treatment completion

    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.

Secondary outcomes

  1. prevalence of adverse reactions

    Time frame: 6 weeks after treatment completion

    The percentage of patients reporting side effects during treatment and the following days until the evaluation of Hp eradication

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Registry information

Official study 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

Acronym: Helicomatri

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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