Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

Helicobacter Pylori Clinical Trial

— NILE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05184491
• Other study ID #: 01013334106
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2021
• Source: National Liver Institute, Egypt
• Contact: Gasser I El-Azab, M.D.
• Phone: 01280250026
• Email: g.elazab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 15, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

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

Locations

Country	Name	City	State
Egypt	National Liver institute - Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (2)

Lead Sponsor	Collaborator
National Liver Institute, Egypt	Future pharmaceutical industries

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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