NCT05184491

Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: National Liver Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Naïve patients - ACO therapy	Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days
DRUG	Naïve patients - LNDL therapy	Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUG	Naïve patients - MNDL therapy	Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUG	Treatment-experienced patients- LNDL therapy	Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUG	Treatment-experienced patients- MNDL therapy	Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-02-01
• Completion: 2022-03-15
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: Egypt