NILE: Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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). |
Drug: Naïve patients - ACO therapy
Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days
|
| Experimental: 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) |
Drug: Naïve patients - LNDL therapy
Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
|
| Experimental: 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) |
Drug: Naïve patients - MNDL therapy
Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
|
| Experimental: 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) |
Drug: Treatment-experienced patients- LNDL therapy
Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
|
| Experimental: 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) |
Drug: Treatment-experienced patients- MNDL therapy
Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
|
Outcome Measures
Primary Outcome Measures
- Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA). [4 weeks after completion of treatment]
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
Secondary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria [Through study completion, an average of 24 weeks]
Safety and tolerability of these regimens will be assessed by reporting adverse events by Individual Case Safety Reports for EPVC
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Liver institute - Menoufia University | Shibīn Al Kawm | Menoufia | Egypt |
Sponsors and Collaborators
- National Liver Institute, Egypt
- Future pharmaceutical industries
Investigators
- Principal Investigator: Gasser El-Azab, M.D., National Liver Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01013334106