Intraluminal Clarithromycin Powder Monotherapy for Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT03516669|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Clarithromycin Drug: Amoxicillin, Clarithromycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 triple therapy which contains a proton pump inhibitor and two antibiotics ( amoxicillin, and clarithromycin) 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 7, 2018|
|Estimated Primary Completion Date :||November 26, 2018|
|Estimated Study Completion Date :||October 26, 2019|
Intraluminal Clarithromycin eradication
20 Patients receive intraluminal Clarithromycin eradication of H. pylori.
Twenty patients receive intraluminal clarithromycin eradication of H. pylor.
Other Name: Klaricid
Oral standard triple therapy
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with triple therapy which contains a proton pump inhibitor and two antibiotics ( amoxicillin, and clarithromycin) for 14 days.
Drug: Amoxicillin, Clarithromycin
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with triple therapy which contains a proton pump inhibitor, amoxicillin and clarithromycin for 14 days.
Other Name: Supercillin, Klaricid
- 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): NCT03516669
|Contact: Tai-cherng Liou, MD||+886-2-25433535 ext firstname.lastname@example.org|
|Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan||Recruiting|
|Taipei, Taiwan, 10449|
|Contact: Tai-cherng Liou, MD 886-2-25433535 ext 3990 email@example.com|
|Principal Investigator:||Tai-cherng Liou, MD||Mackay Memorial Hospital|