A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
NCT ID: NCT06050824
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2022-07-21
2023-07-19
Brief Summary
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The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.
About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.
All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.
Biopsies will be classified using the Updated Sydney system of classification of gastritis
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Detailed Description
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1. patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
2. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.
H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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concomitant
Clarithro -pantoprazole- Metronidazole - Amoxicyllin
Comparing Load and Concomitant therapy
Levofloxacin - Omeprazole - nitazoxanide - doxycycline
LOAD
Levofloxacin -omeprazole- nitazoxanide- Doxycycline
Comparing Load and Concomitant therapy
Levofloxacin - Omeprazole - nitazoxanide - doxycycline
Interventions
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Comparing Load and Concomitant therapy
Levofloxacin - Omeprazole - nitazoxanide - doxycycline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Allergy to any drugs used in our protocol
3. Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
4. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
5. Presence of GI malignancy.
6. Pregnancy or lactating women.
7. Unable or refuse to give consent. -
ALL
No
Sponsors
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Helwan University
OTHER
Responsible Party
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Hala Hany Shehata
Principle Investigator
Locations
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Faculty of Medicine, Helwan University
Cairo, , Egypt
Countries
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Other Identifiers
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ENDM0003
Identifier Type: -
Identifier Source: org_study_id
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