Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Doxycycline; Drug: Levofloxacin 500mg

• Registration Number: NCT04348786
• Lead Sponsor: Damascus Hospital

Brief Summary

Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Primary Completion: 2020-08-30
• Status Verified: 2020-09
• Study Completion: 2020-09-01
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
• Positive rapid urease test (CLOtest).
• Histologic evidence of H. pylori by modified Giemsa staining.
• Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria

• Children and teenagers aged less than 18 years.
• Previous eradication treatment for H. pylori.
• Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
• History of gastrectomy.
• Gastric malignancy, including adenocarcinoma and lymphoma,
• Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
• Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
• Contraindication to treatment drugs.
• Pregnant or lactating women.
• Severe concurrent disease.
• Liver cirrhosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycyclien	Doxycycline	Measure eradication rate of Helicobacter pylori infection with Doxycycline and bismuth subsalicylate
Levofloxacine	Levofloxacin 500mg	Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori infection	8 week from begning of treatment	Eradication rate of Helicobacter infected patients

Trial Locations

Locations (1)

General Assembly of Damascus Hospital; 🇸🇾 Damascus, Syrian Arab Republic