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

National Liver Institute, Egypt

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori

Treatments: Drug: Treatment-experienced patients- MNDL therapy; Drug: Naïve patients - LNDL therapy; Drug: Naïve patients - MNDL therapy; Drug: Treatment-experienced patients- LNDL therapy; Drug: Naïve patients - ACO therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05184491

01013334106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 5 patient groups

Naïve patients - ACO therapy

Active Comparator group

Description:

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).

Treatment:

Drug: Naïve patients - ACO therapy

Naïve patients - LNDL therapy

Experimental group

Description:

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)

Treatment:

Drug: Naïve patients - LNDL therapy

Naïve patients - MNDL therapy

Experimental group

Description:

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)

Treatment:

Drug: Naïve patients - MNDL therapy

Treatment-experienced patients- LNDL therapy

Experimental group

Description:

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)

Treatment:

Drug: Treatment-experienced patients- LNDL therapy

Treatment-experienced patients- MNDL therapy

Experimental group

Description:

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)

Treatment:

Drug: Treatment-experienced patients- MNDL therapy