Helicobacter Pylori
Conditions
Keywords
Helicobacter pylori, Eradication, nitazoxanide, Lansoprazole, LOAD
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.
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.
Interventions
DRUGNaïve patients - ACO therapy
Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days
DRUGNaïve patients - LNDL therapy
Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUGNaïve patients - MNDL therapy
Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUGTreatment-experienced patients- LNDL therapy
Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
DRUGTreatment-experienced patients- MNDL therapy
Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
Sponsors
Future pharmaceutical industries
National Liver Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactGasser I El-Azab, M.D.
Backup ContactSherif Abdel-Salam, M.D.
Outcome results
None listed