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

NCT ID: NCT02422706

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-12-31

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 .

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.

Conditions

Helicobacter-associated Gastritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Metronidazole(MTZ)

Intervention Type: DRUG

Metronidazole 500 mg twice daily

Omeprazole

Intervention Type: DRUG

Omeprazole 20 twice daily

Clarithromycin

Intervention Type: DRUG

KLacid twice daily

Group II

Nitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily & Clarithromycin 500 mg twice daily for 14 days.

40 patients.

Group Type: EXPERIMENTAL

Nitazoxanide

Intervention Type: DRUG

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

Clarithromycin

Intervention Type: DRUG

KLacid twice daily

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

Group Type: EXPERIMENTAL

Nitazoxanide

Intervention Type: DRUG

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

Omeprazole

Intervention Type: DRUG

Omeprazole 20 twice daily

Levofloxacin

Intervention Type: DRUG

Tavanic. Tavacin

Doxicycline

Intervention Type: DRUG

Vibramycin 100 mg twice daily

Interventions

Nitazoxanide

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

Intervention Type: DRUG

Metronidazole(MTZ)

Metronidazole 500 mg twice daily

Intervention Type: DRUG

Omeprazole

Omeprazole 20 twice daily

Intervention Type: DRUG

Clarithromycin

KLacid twice daily

Intervention Type: DRUG

Levofloxacin

Tavanic. Tavacin

Intervention Type: DRUG

Doxicycline

Vibramycin 100 mg twice daily

Intervention Type: DRUG

Other Intervention Names

Alenia,parazoxanide,Nitclean; Flagyl; Omepak. Napizole; KLacid; Levofloxacin once daily; vibramycin. Doxymycin

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Sherief Abd-Elsalam

OTHER

Sponsor Role: lead

Responsible Party

Sherief Abd-Elsalam

Tanta university

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mona AH Shehata, Prof

Role: STUDY_CHAIR

liver dis dept

Sherief Abd-Elsalam, Consultant

Role: STUDY_DIRECTOR

Division of Gastroenterology and Hepatology- Tanta

Raghda Talaat, Prof

Role: STUDY_CHAIR

Microbiology

Huda Elmesseri, Specialist

Role: STUDY_CHAIR

liver diseases dept.-Elmahalla hospital

Locations

Tanta university hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Sherief Abd-Elsalam

Role: primary

Sherif_tropical@yahoo.com

00201000040794

References

Shehata MA, Talaat R, Soliman S, Elmesseri H, Soliman S, Abd-Elsalam S. Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection. Helicobacter. 2017 Oct;22(5). doi: 10.1111/hel.12395. Epub 2017 May 19.

Reference Type: DERIVED

PMID: 28524341 (View on PubMed)

Other Identifiers

HELICOBACTER NEW TREATMENT

Identifier Type: -

Identifier Source: org_study_id