A Unique Regimen for Treatment of Helicobacter Pylori Infection

NCT ID: NCT03491995

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-04-01

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 .

Conditions

Helicobacter Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Quadruple therapy

Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin

Group Type: EXPERIMENTAL

Quadruple therapy

Intervention Type: DRUG

Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin

Classic treatment

Omeprazole, clarithromycin, amoxicillin

Group Type: ACTIVE_COMPARATOR

Classic treatment

Intervention Type: DRUG

Omeprazole, amoxycillin, clarithromycin

Interventions

Quadruple therapy

Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin

Intervention Type: DRUG

Classic treatment

Omeprazole, amoxycillin, clarithromycin

Intervention Type: DRUG

Other Intervention Names

Moxiflox, Downoprazol, Nanazoxid, Doxymycin; Downoprazol, Emox, Klacid

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sherief Abd-Elsalam

OTHER

Sponsor Role: lead

Responsible Party

Sherief Abd-Elsalam

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ayman Yousry, Prof

Role: PRINCIPAL_INVESTIGATOR

Head of Hepatology and infectious diseases dept.-Cairo University

Walied El-Hossary, MD

Role: STUDY_DIRECTOR

Hepatology and infectious diseases dept.-Cairo University

Mohamed Alboraie, MD

Role: STUDY_CHAIR

Internal Medicine dept.-Alazhar University

Sherief Abd-Elsalam, MD

Role: STUDY_CHAIR

Hepatology and Infectious diseases- Tanta University

Asem Elfert, Prof

Role: STUDY_CHAIR

Hepatology and Infectious diseases- Tanta University

Hussein A Elamin, Prof

Role: STUDY_CHAIR

Internal Medicine-Assuit University

Mohamed Adel Elbasiony, MD

Role: STUDY_CHAIR

Internal Medicine- Mansoura University

Locations

Sherief Abd-Elsalam

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sherief Abd-Elsalam, MD

Role: CONTACT

sheriefabdelsalam@yahoo.com

00201147773440

Facility Contacts

Sherief Abd-elsalam, lecturer

Role: primary

Sherif_tropical@yahoo.com

00201000040794

Other Identifiers

Helicobacter study

Identifier Type: -

Identifier Source: org_study_id