- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491995
A Unique Regimen for Treatment of Helicobacter Pylori Infection
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Recruiting
- Sherief Abd-Elsalam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
Other Names:
|
ACTIVE_COMPARATOR: Classic treatment
Omeprazole, clarithromycin, amoxicillin
|
Omeprazole, amoxycillin, clarithromycin
Other Names:
|
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
Sponsor
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
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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