Intraluminal Amoxicillin Powder Monotherapy for Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT03521726|
Recruitment Status : Completed
First Posted : May 10, 2018
Last Update Posted : February 15, 2019
Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.
The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that 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 Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Several strategies have been proposed to overcome the declining eradication rate, including (1) extending the treatment duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The investigators aim to evaluate the efficacy of Amoxicillin powder in the Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is performed.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Amoxicillin Drug: Rabeprazole, Amoxicillin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||20 participants receive intraluminal eradication of H. pylori. Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with High-dose PPI-amoxicillin dual therapy (rabeprazole 20 mg and amoxicillin 750 mg 4 times/day) for 14 days.|
|Masking:||None (Open Label)|
|Official Title:||Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan|
|Actual Study Start Date :||May 11, 2018|
|Actual Primary Completion Date :||February 12, 2019|
|Actual Study Completion Date :||February 12, 2019|
Intraluminal Amoxicillin eradication
20 Patients receive intraluminal Amoxicillin eradication of H. pylori.
Twenty patients receive Intraluminal Amoxicillin eradication for H. pylori.
Other Name: Supercillin
Rabeprazole, Amoxicillin dual therapy
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole and Amoxicillin) for 14 days.
Drug: Rabeprazole, Amoxicillin
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole, Amoxicillin) for 14 days.
Other Name: Pariet, Supercillin
- Eradication rate in the intraluminal therapy [ Time Frame: 6 weeks after finishing therapy ]Eradication rate in the intraluminal therapy C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.
- Overall eradication rates [ Time Frame: 3-6 months after finishing intraluminal therapy ]Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies.
- Incidence of adverse effects in the intraluminal therapy. [ Time Frame: within 7 days after finishing the intraluminal therapy ]Incidence of adverse effects were evaluated for Participants who had or had not finished the intraluminal therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521726
|Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan|
|Taipei, Taiwan, 10449|
|Principal Investigator:||Tai-cherng Liou, MD||Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital|