Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management (NILE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gasser I El-Azab, M.D.; Phone Number: 01280250026; Email: g.elazab@gmail.com
• Study Contact Backup: Name: Sherif Abdel-Salam, M.D.; Phone Number: 01063319696; Email: sherif.abdelbaky@med.tanta.edu.eg

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Recruiting
      • National Liver institute - Menoufia University
      • Contact: Gasser Elazab, M.D.; Phone Number: 01280250026; Email: g.elazab@gmail.com
      • Contact: Ibrahim Eldemshehy, M.S.; Phone Number: 01013334106; Email: brahim.eldemshehy@gmail.com
      • Principal Investigator: Gasser Elazab, M.D.
      • Sub-Investigator: Ahmed Abdel Aleem, M.D.
      • Sub-Investigator: Ehab Fawzy, M.D.
      • Sub-Investigator: Ezzat Ali, M.D.
      • Sub-Investigator: Osama Abdel Aal, M.D.
      • Sub-Investigator: Sherif Abdel Salam, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Liver Institute, Egypt
• Collaborators: Future pharmaceutical industries
• Investigators: Principal Investigator: Gasser El-Azab, M.D., National Liver Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication; Lansoprazole; nitazoxanide; LOAD
• Other Study ID Numbers: 01013334106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No