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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02422706
Enrollment
120
Registered
2015-04-21
Start date
2015-01-31
Completion date
2018-12-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter-associated Gastritis

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.

Interventions

DRUGNitazoxanide

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

DRUGMetronidazole(MTZ)

Metronidazole 500 mg twice daily

DRUGOmeprazole

Omeprazole 20 twice daily

DRUGClarithromycin

KLacid twice daily

DRUGLevofloxacin

Tavanic. Tavacin

DRUGDoxicycline

Vibramycin 100 mg twice daily

Sponsors

Tanta University
CollaboratorOTHER
Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

blinding was applied by using consecutively numbered envelopes that contained the treatment assignments

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with proven eradication of helicobacter6 weeksNumber of patients with proven eradication of helicobacter after 6 weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026