Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

NCT ID: NCT05184491

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-03-15

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.

Conditions

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Helicobacter Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Naïve patients - ACO therapy

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Naïve patients - LNDL therapy

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Naïve patients - MNDL therapy

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Treatment-experienced patients- LNDL therapy

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

Treatment-experienced patients- MNDL therapy

Intervention Type DRUG

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

Interventions

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Naïve patients - ACO therapy

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

Intervention Type DRUG

Naïve patients - LNDL therapy

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

Intervention Type DRUG

Naïve patients - MNDL therapy

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

Intervention Type DRUG

Treatment-experienced patients- LNDL therapy

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

Intervention Type DRUG

Treatment-experienced patients- MNDL therapy

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Future pharmaceutical industries

UNKNOWN

Sponsor Role collaborator

National Liver Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Gasser Ibrahim El-Azab

Professor of Hepatology and Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gasser El-Azab, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Liver Institute

Locations

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National Liver institute - Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Gasser I El-Azab, M.D.

Role: CONTACT

01280250026

Sherif Abdel-Salam, M.D.

Role: CONTACT

01063319696

Facility Contacts

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Gasser Elazab, M.D.

Role: primary

01280250026

Ibrahim Eldemshehy, M.S.

Role: backup

01013334106

Other Identifiers

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01013334106

Identifier Type: -

Identifier Source: org_study_id

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