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A Two Week Nitazoxanidebased Quadruple Regimen

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02621359
Enrollment
100
Registered
2015-12-03
Start date
2015-01-31
Completion date
2022-12-31
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Brief 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 .

Detailed 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.

Interventions

DRUGNitazoxanide

Nitazoxanide 500 mg twice daily

DRUGLevofloxacin

Levofloxacin 500 mg once daily

Doxycyclin 100 mg twice daily

DRUGOmeprazole

Omeprazole 40 mg twice daily

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with eradicated helicobacter1 yearThe total number of patients with eradicated helicobacter

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, lecturer
sherif_tropical@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026