Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

NCT05184491 | Unknown Phase 4

• 1 other identifier: 01013334106
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Keywords

Helicobacter pylori; Eradication; nitazoxanide; Lansoprazole; LOAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria

  Through study completion, an average of 24 weeks

Study Arms (5)

Naïve patients - ACO therapy

ACTIVE COMPARATOR

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 - LNDL therapy

EXPERIMENTAL

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 - MNDL therapy

EXPERIMENTAL

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

Treatment-experienced patients- LNDL therapy

EXPERIMENTAL

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

Treatment-experienced patients- MNDL therapy

EXPERIMENTAL

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

Interventions

Naïve patients - ACO therapy DRUG

Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days

Naïve patients - ACO therapy

Naïve patients - LNDL therapy DRUG

Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days

Naïve patients - LNDL therapy

Naïve patients - MNDL therapy DRUG

Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days

Naïve patients - MNDL therapy

Treatment-experienced patients- LNDL therapy DRUG

Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days

Treatment-experienced patients- LNDL therapy

Treatment-experienced patients- MNDL therapy DRUG

Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days

Treatment-experienced patients- MNDL therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Liver Institute, Egypt: lead
• Future pharmaceutical industries: collaborator

Study Sites (1)

National Liver institute - Menoufia University

Shibīn al Kawm, Menoufia, Egypt

RECRUITING

Study Officials

• Gasser El-Azab, M.D.

  National Liver Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gasser I El-Azab, M.D.

CONTACT

01280250026; g.elazab@gmail.com

Sherif Abdel-Salam, M.D.

CONTACT

01063319696; sherif.abdelbaky@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatology and Gastroenterology

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: January 11, 2022
• Study Start: October 15, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 15, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)