Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

Phase 4

• Conditions: Helicobacter Pylori
• Interventions: Drug: Naïve patients - ACO therapy; Drug: Naïve patients - LNDL therapy; Drug: Naïve patients - MNDL therapy; Drug: Treatment-experienced patients- LNDL therapy; Drug: Treatment-experienced patients- MNDL therapy

• Registration Number: NCT05184491
• Lead Sponsor: National Liver Institute, Egypt

Brief Summary

The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.

Detailed Description

This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-11-13
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients presented with dyspepsia for more than one month with positive H. pylori antigen test in stool

Exclusion Criteria

• Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfate within the two weeks before study entry, recent use of antibiotics (within one month), allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, any current malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naïve patients - ACO therapy	Naïve patients - ACO therapy	One hundred patients naive to H. Pylori eradication therapy will receive ACO therapy for 14 days (amoxicillin 1 g with breakfast and dinner, clarithromycin 500 mg with breakfast and dinner and lansoprazole 40 mg twice daily before meals).
Naïve patients - LNDL therapy	Naïve patients - LNDL therapy	One hundred patients naive to H. Pylori eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
Naïve patients - MNDL therapy	Naïve patients - MNDL therapy	One hundred patients naive to H. Pylori eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
Treatment-experienced patients- LNDL therapy	Treatment-experienced patients- LNDL therapy	One hundred patients who were unresponsive to previous eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
Treatment-experienced patients- MNDL therapy	Treatment-experienced patients- MNDL therapy	One hundred patients who were unresponsive to previous eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)

Primary Outcome Measures

Name	Time	Method
Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA).	4 weeks after completion of treatment	successful eradication of H. pylori confirmed by H. pylori antigen test in stool. Monocent, Inc.'s H. pylori Antigen Test System is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. The patient has to be asked to collect the specimen avoiding any possible contact with urine or water. The patient submitted to the test should not be under antibiotic or anti-acid treatments.; immunoassay for the qualitative and quantitative detection of H. li tiihtlIt iitdd id ithiy fthqlitti pylori antigen in human stool. diif iblHli

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria	Through study completion, an average of 24 weeks	Safety and tolerability of these regimens will be assessed by reporting adverse events by Individual Case Safety Reports for EPVC

Trial Locations

Locations (1)

National Liver institute - Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt