Back to resultsA Unique Regimen for Treatment of Helicobacter Pylori Infection
Primary Purpose
Helicobacter Infections
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Quadruple therapy
Classic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Infections
Eligibility Criteria
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.
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quadruple therapy
Classic treatment
Arm Description
Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
Omeprazole, clarithromycin, amoxicillin
Outcomes
Primary Outcome Measures
Number of patients with eradicated Helicobacter infection
Number of patients with eradicated infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03491995
Brief Title
A Unique Regimen for Treatment of Helicobacter Pylori Infection
Official Title
A Unique Quadruple Regimen for of Helicobacter Pylori
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadruple therapy
Arm Type
Experimental
Arm Description
Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
Arm Title
Classic treatment
Arm Type
Active Comparator
Arm Description
Omeprazole, clarithromycin, amoxicillin
Intervention Type
Drug
Intervention Name(s)
Quadruple therapy
Other Intervention Name(s)
Moxiflox, Downoprazol, Nanazoxid, Doxymycin
Intervention Description
Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
Intervention Type
Drug
Intervention Name(s)
Classic treatment
Other Intervention Name(s)
Downoprazol, Emox, Klacid
Intervention Description
Omeprazole, amoxycillin, clarithromycin
Primary Outcome Measure Information:
Title
Number of patients with eradicated Helicobacter infection
Description
Number of patients with eradicated infection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Yousry, Prof
Organizational Affiliation
Head of Hepatology and infectious diseases dept.-Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walied El-Hossary, MD
Organizational Affiliation
Hepatology and infectious diseases dept.-Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Alboraie, MD
Organizational Affiliation
Internal Medicine dept.-Alazhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Hepatology and Infectious diseases- Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Asem Elfert, Prof
Organizational Affiliation
Hepatology and Infectious diseases- Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hussein A Elamin, Prof
Organizational Affiliation
Internal Medicine-Assuit University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed Adel Elbasiony, MD
Organizational Affiliation
Internal Medicine- Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Unique Regimen for Treatment of Helicobacter Pylori Infection
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