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A Unique Regimen for Treatment of Helicobacter Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03491995
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Helicobacter Infections Drug: Quadruple therapy Drug: Classic treatment Phase 3

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Unique Quadruple Regimen for of Helicobacter Pylori
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
Experimental: Quadruple therapy
Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
Drug: Quadruple therapy
Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
Other Name: Moxiflox, Downoprazol, Nanazoxid, Doxymycin

Active Comparator: Classic treatment
Omeprazole, clarithromycin, amoxicillin
Drug: Classic treatment
Omeprazole, amoxycillin, clarithromycin
Other Name: Downoprazol, Emox, Klacid

Primary Outcome Measures :
  1. Number of patients with eradicated Helicobacter infection [ Time Frame: 6 months ]
    Number of patients with eradicated infection

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03491995

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Contact: Sherief Abd-Elsalam, MD 00201147773440

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Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794   
Sponsors and Collaborators
Sherief Abd-Elsalam
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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

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Responsible Party: Sherief Abd-Elsalam, Investigator, Tanta University Identifier: NCT03491995    
Other Study ID Numbers: Helicobacter study
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action