A Unique Regimen for Treatment of Helicobacter Pylori Infection

April 7, 2018 updated by: Sherief Abd-Elsalam

A Unique Quadruple Regimen for of Helicobacter Pylori

The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.

However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent

Exclusion Criteria:

  • Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Quadruple therapy
Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
Drug: Quadruple therapy
Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
Other Names:
  • Moxiflox, Downoprazol, Nanazoxid, Doxymycin
ACTIVE_COMPARATOR: Classic treatment
Omeprazole, clarithromycin, amoxicillin
Drug: Classic treatment
Omeprazole, amoxycillin, clarithromycin
Other Names:
  • Downoprazol, Emox, Klacid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with eradicated Helicobacter infection
Time Frame: 6 months
Number of patients with eradicated infection
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Ayman Yousry, Prof, Head of Hepatology and infectious diseases dept.-Cairo University
  • Study Director: Walied El-Hossary, MD, Hepatology and infectious diseases dept.-Cairo University
  • Study Chair: Mohamed Alboraie, MD, Internal Medicine dept.-Alazhar University
  • Study Chair: Sherief Abd-Elsalam, MD, Hepatology and Infectious diseases- Tanta University
  • Study Chair: Asem Elfert, Prof, Hepatology and Infectious diseases- Tanta University
  • Study Chair: Hussein A Elamin, Prof, Internal Medicine-Assuit University
  • Study Chair: Mohamed Adel Elbasiony, MD, Internal Medicine- Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (ACTUAL)

April 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 7, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Helicobacter study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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