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

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 .

Conditions

• Helicobacter-associated Gastritis

Interventions

DRUG

Nitazoxanide

Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection

DRUG

Metronidazole(MTZ)

Metronidazole 500 mg twice daily

DRUG

Omeprazole

Omeprazole 20 twice daily

DRUG

Clarithromycin

KLacid twice daily

DRUG

Levofloxacin

Tavanic. Tavacin

DRUG

Doxicycline

Vibramycin 100 mg twice daily

Sponsors & Collaborators

• Tanta University

  collaborator OTHER

• Sherief Abd-Elsalam

  lead OTHER

Principal Investigators

• Mona AH Shehata, Prof · liver dis dept

• Sherief Abd-Elsalam, Consultant · Division of Gastroenterology and Hepatology- Tanta

• Raghda Talaat, Prof · Microbiology

• Huda Elmesseri, Specialist · liver diseases dept.-Elmahalla hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Egypt

Study Locations