A Unique Regimen for Treatment of Helicobacter Pylori Infection

NCT03491995 | Unknown Phase 3 DMC

• 1 other identifier: Helicobacter study
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Helicobacter Infections

Outcome Measures

Primary Outcomes (1)

• Number of patients with eradicated Helicobacter infection

  Number of patients with eradicated infection

  6 months

Study Arms (2)

Quadruple therapy

EXPERIMENTAL

Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin

Drug: Quadruple therapy

Classic treatment

ACTIVE COMPARATOR

Omeprazole, clarithromycin, amoxicillin

Drug: Classic treatment

Interventions

Quadruple therapy DRUG

Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin

Also known as: Moxiflox, Downoprazol, Nanazoxid, Doxymycin

Quadruple therapy

Classic treatment DRUG

Omeprazole, amoxycillin, clarithromycin

Also known as: Downoprazol, Emox, Klacid

Classic treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Ayman Yousry, Prof

  Head of Hepatology and infectious diseases dept.-Cairo University

  PRINCIPAL INVESTIGATOR

• Walied El-Hossary, MD

  Hepatology and infectious diseases dept.-Cairo University

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201147773440; sheriefabdelsalam@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

EG (1)