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OpenTrials
Completed

NCT Number: NCT06050824

A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.

The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.

About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.

All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.

Biopsies will be classified using the Updated Sydney system of classification of gastritis

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Key information

Conditions

H. Pylori Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Helwan University

Cairo, 11795, Egypt

About this study

The patients will be randomized (closed envelopes) into one of two groups:

  • patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
  • patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.

H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion criteria

  • Patients recently (within 6 months) treated with anti-H. pylori therapy.
  • Allergy to any drugs used in our protocol
  • Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
  • Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
  • Presence of GI malignancy.
  • Pregnancy or lactating women.
  • Unable or refuse to give consent. -

Treatment and study plan

Comparing Load and Concomitant therapy

Drug

Levofloxacin - Omeprazole - nitazoxanide - doxycycline

Other names: Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

Primary outcomes

  1. Eradication of H. pylori infection after treatment

    Time frame: 4 weeks after end of treatment

    Negative stool antigen test for H.pylori

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2023
Registry last updated
Sep 26, 2023

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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