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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN01756929 |
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Date of registration:
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29/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mastic Gum and Helicobacter Pylori eradication: an in vivo pilot study
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Scientific title:
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Date of first enrolment:
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01/12/2006 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN01756929 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial with three arms (Treatment)
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Konstantinos
Dabos |
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Address:
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Helenas Venizelou 2
821-00
Chios
Greece |
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Telephone:
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Email:
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kostasophia@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients tested positive for H. pylori
2. Adults of either sex aged between 18 and 75 years of age
Exclusion criteria: 1. Pregnancy
2. Malignancy
3. Allergies to pantoprazole, amoxicillin, clarithromycin
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Helicobacter pylori gastritis
Infections and Infestations
Gastritis and duodenitis
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Intervention(s)
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Patients positive to Helicobacter pylori will be randomised to receive one of the following:
1. Mastic gum 2 g per day for 14 days
2. Mastic gum 2 g per day and pantoprazole 40 mg per day for 14 days
3. Pantoprazole 40 mg per day, amoxicillin 2 g per day and clarithromycin 1 g per day for 10 days
Follow up was two months after the end of the treatment for all study arms.
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Primary Outcome(s)
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Eradication of Helicobacter pylori, measured at five weeks after the end of treatment.
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Secondary Outcome(s)
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Helicobacter pylori load in patients remaining H. pylori positive, measured at five weeks after the end of treatment.
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Source(s) of Monetary Support
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The Chios Mastic Gum Producers Cooperative (Greece)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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