Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
Study Details
Study Description
Brief 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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: group I Metronidazole(MTZ) 500mg twice daily ,Omeprazole 20 mg twice daily as (Proton Pump Inhibitor (PPI)& Clarithromycin 500 mg twice daily .for 14 days . 40 patients |
Drug: Metronidazole(MTZ)
Metronidazole 500 mg twice daily
Other Names:
Drug: Omeprazole
Omeprazole 20 twice daily
Other Names:
Drug: Clarithromycin
KLacid twice daily
Other Names:
|
| Experimental: Group II Nitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily & Clarithromycin 500 mg twice daily for 14 days. 40 patients. |
Drug: Nitazoxanide
Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection
Other Names:
Drug: Clarithromycin
KLacid twice daily
Other Names:
|
| Experimental: Group III Levofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily & Doxicycline 100 mg once daily (LOND). 40 patients |
Drug: Nitazoxanide
Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection
Other Names:
Drug: Omeprazole
Omeprazole 20 twice daily
Other Names:
Drug: Levofloxacin
Tavanic. Tavacin
Other Names:
Drug: Doxicycline
Vibramycin 100 mg twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of patients with proven eradication of helicobacter [6 weeks]
Number of patients with proven eradication of helicobacter after 6 weeks
Eligibility Criteria
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:
-
Previous gastric or duedenal operations or malignancy.
-
Active GIT bleeding.
-
Pregnancy.
-
Previous treatment for HP.
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Current use of Antiacids ( proton pump inhibitor ( PPI ), H2 receptor antagonist) , anticoagulant, or recent use of antibiotics (within 6 weeks).
-
Allergy to any medication included in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta university hospital | Cairo | Egypt |
Sponsors and Collaborators
- Sherief Abd-Elsalam
- Tanta University
Investigators
- Study Chair: Mona AH Shehata, Prof, liver dis dept
- Study Director: Sherief Abd-Elsalam, Consultant, Division of Gastroenterology and Hepatology- Tanta
- Study Chair: Raghda Talaat, Prof, Microbiology
- Study Chair: Huda Elmesseri, Specialist, liver diseases dept.-Elmahalla hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HELICOBACTER NEW TREATMENT