Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to
Conditions
Keywords
Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test
Brief summary
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
Detailed description
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
Interventions
DRUGSequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID
The eradication rate of H. Pylori with levofloxacin-based sequential therapy
DRUGTriple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
The eradication rate of H. Pylori with moxifloxacin-based triple therapy
Sponsors
Iyad Naeem Muhammad, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients were randomized into two regimens: 1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or 2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Successful isolation of H. pylori from the patient, and 2. patients of at least 18 years of age.
Exclusion criteria
1. age under 18 years 2. presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases), 3. previous gastric surgery, 4. allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori status one month after treatment. | One month after finishing with therapy. | Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. | One month after finishing with therapy. | Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance |
| Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. | One month after finishing with therapy. | Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities). |
Countries
Pakistan
Outcome results
None listed