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

Helicobacter-associated Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422706
• Other study ID #: HELICOBACTER NEW TREATMENT
• Status: Recruiting
• Phase: Phase 3
• First received: April 13, 2015
• Last updated: April 23, 2017
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

Helicobacter pylori (H.pylori) is a small, Gram-negative spirochete inhabiting the mucous layer overlying the gastric epithelial cells in humans. It is the most common prevalent chronic human bacterial infection and the most common cause of gastritis worldwide;. Furthermore, according to the World Health Organization, HP is classified as a type 1 carcinogen and is the primary cause of peptic ulcer disease, gastric carcinoma, and mucosa-associated lymphoid tissue lymphomas .

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens.Omeprazole,Amoxicillin &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 study by Rokkas , et al., 2008 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.

Nitazoxanide (NTZ) is an antibiotic with microbiological characteristics similar to those of Metronidazole which was sittled as a therapy for intestinal protozoa and helminthic infection,and was studied as an additional therapy with Peg Interferon and Ribavirin for chronic hepatitis C virus (HCV) .

In the last few years Nitazoxanide was evaluated as a single agent therapy for H. Pylori infection showing controversed results.. However (NTZ) based regimens were recently studied showing interesting results without the apparent problem of resistance as Metronidazole with nearby cost.Moreover ;Levofloxacin,PPI,NTZ&Doxycycline (LOAD) regimen with very good results in H.pylori infection ~90% cure rate..But uptil now there are no actual similar reported trials in Egypt.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis
• Helicobacter-associated Gastritis

Intervention

Drug:
• Nitazoxanide
Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection
• Metronidazole(MTZ)
Metronidazole 500 mg twice daily
• Omeprazole
Omeprazole 20 twice daily
• Clarithromycin
KLacid twice daily
• Levofloxacin
Tavanic. Tavacin
• Doxicycline
Vibramycin 100 mg twice daily

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with proven eradication of helicobacter	Number of patients with proven eradication of helicobacter after 6 weeks	6 weeks