Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

Last updated: December 21, 2021
Sponsor: National Liver Institute, Egypt
Overall Status: Active - Recruiting

Phase

4

Condition

Helicobacter Pylori

Treatment

N/A

Clinical Study ID

NCT05184491
01013334106
  • Ages 18-70
  • All Genders

Study Summary

The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients presented with dyspepsia for more than one month with positive H. pyloriantigen test in stool

Exclusion

Exclusion Criteria:

  • Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfatewithin the two weeks before study entry, recent use of antibiotics (within one month),allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, anycurrent malignancy.

Study Design

Total Participants: 500
Study Start date:
October 15, 2021
Estimated Completion Date:
March 15, 2022

Study Description

This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.

Connect with a study center

  • National Liver institute - Menoufia University

    Shibīn Al Kawm, Menoufia
    Egypt

    Active - Recruiting

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