Overview

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance . However, a recent study based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an intention-to-treat (ITT) basis, and will fail in ~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue warranting the investigation of other agents. 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 .
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sherief Abd-Elsalam
Collaborator:
Tanta University
Treatments:
Clarithromycin
Doxycycline
Levofloxacin
Metronidazole
Nitazoxanide
Ofloxacin
Omeprazole
Criteria
Inclusion Criteria:

- Consecutive patients with dyspeptic symptoms undergoing upper Gasto-intestinal tract
(GIT) endoscopy selecting HP infected patients to be recruited for the study.

- Patients must have had Helicobacter Pylori - induced disease confirmed by endoscopy
and HP monoclonal stool antigen.

Exclusion Criteria:

1. Previous gastric or duedenal operations or malignancy.

2. Active GIT bleeding.

3. Pregnancy.

4. Previous treatment for HP.

5. Current use of Antiacids ( proton pump inhibitor ( PPI ), H2 receptor antagonist) ,
anticoagulant, or recent use of antibiotics (within 6 weeks).

6. Allergy to any medication included in the study.