A Two Week Nitazoxanidebased Quadruple Regimen

Dyspepsia Clinical Trial

Official title:

A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02621359
• Other study ID #: Quadruple therapy
• Status: Recruiting
• Phase: Phase 3
• First received: November 27, 2015
• Last updated: December 30, 2017
• Start date: January 2015
• Est. completion date: December 2022

Study information

• Verified date: December 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, lecturer
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Description:

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with helicobacter infection.

• in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion Criteria:

• Patients under 18 or over 65 years of age.

• Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies

• pregnancy/lactation

• having contraindication or allergy to any of the study drugs

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Nitazoxanide
Nitazoxanide 500 mg twice daily
• Levofloxacin
Levofloxacin 500 mg once daily
• Doxycyclin
Doxycyclin 100 mg twice daily
• Omeprazole
Omeprazole 40 mg twice daily

Locations

Country	Name	City	State
Egypt	Tropical medicine dept.-Tanta university hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with eradicated helicobacter	The total number of patients with eradicated helicobacter	1 year