Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nitazoxanide and Lansoprazole Based Regimens for Managing Helicobacter Pylori in Egyptian Patients (NILE Study)

Conditions
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Helicobacter Pylori

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naïve patients - ACO therapy<br>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). | Drug: Naïve patients - ACO therapy<br>* Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days<br>|
| Experimental: Naïve patients - LNDL therapy<br>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) | Drug: Naïve patients - LNDL therapy<br>* Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days<br>|
| Experimental: Naïve patients - MNDL therapy<br>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) | Drug: Naïve patients - MNDL therapy<br>* Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days<br>|
| Experimental: Treatment-experienced patients- LNDL therapy<br>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) | Drug: Treatment-experienced patients- LNDL therapy<br>* Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days<br>|
| Experimental: Treatment-experienced patients- MNDL therapy<br>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) | Drug: Treatment-experienced patients- MNDL therapy<br>* Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA). | 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 | 4 weeks after completion of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOAD, Helicobacter pylori, Eradication, nitazoxanide, Lansoprazole