Helicobacter Pylori Clinical Trial
— NILEOfficial title:
Nitazoxanide and Lansoprazole Based Regimens for Managing Helicobacter Pylori in Egyptian Patients (NILE Study)
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | March 15, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Liver institute - Menoufia University | Shibin Al Kawm | Menoufia |
Lead Sponsor | Collaborator |
---|---|
National Liver Institute, Egypt | Future pharmaceutical industries |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria | Safety and tolerability of these regimens will be assessed by reporting adverse events by Individual Case Safety Reports for EPVC | Through study completion, an average of 24 weeks |
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