Status:
COMPLETED
Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a G...
Detailed Description
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). The treat...
Eligibility Criteria
Inclusion
- Patients aged between 20 years and 75 years
- Patients have H. pylori infection and have not treated with oral antibiotics
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Exclusion
- Children and teenagers aged less than 20 years or adult greater than 75 years
- Contraindication for endoscopic examination or food retention in the gastric lumen.
- History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
- Contraindication to treatment drugs: previous allergic reaction to Proton pump inhibitors, Amoxicillin, Levofloxacin, Acetylcystein, and pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of liver, incurable malignant disease
- Patients who cannot give informed consent by himself or herself.
Key Trial Info
Start Date :
June 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03832465
Start Date
June 14 2019
End Date
December 27 2020
Last Update
February 5 2021
Active Locations (1)
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1
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Taipei, Taiwan, 10449