Status:
COMPLETED
ILTHPI - Comparison of Medicament Containing Tetracycline, Metronidazole, Bismuth Versus Amoxicillin, Metronidazole, Clarithromycin
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium. The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and colonizes th...
Detailed Description
During the endoscopic examination, patient is sedated with intravenous Midazolam 5mg and Fentanyl 0.05mg, the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). Th...
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
- Patients will be excluded from the study if any one of the following criteria is present:
- 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 antibiotics of study, PPI (Lansoprazole), Acetylcysteine and Sucralfate; 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 :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04853875
Start Date
April 19 2021
End Date
December 16 2022
Last Update
January 4 2023
Active Locations (1)
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1
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
Taipei, Taiwan, 10449