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ISRCTN
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ISRCTN01756929
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ClinicalTrials.gov identifier
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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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Acronym
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MGHP
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Serial number at source
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MGHP05
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Study hypothesis
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Mastic gum is effective in eradicating Helicobacter pylori in vivo.
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Ethics approval
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Ethics approval received from the Greek Medicines Agency Ethics Board on the 18th December 2005 (ref: MGCGH0032/06).
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Study design
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Randomised controlled trial with three arms
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Helicobacter pylori gastritis
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Participants - inclusion criteria
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1. Patients tested positive for H. pylori
2. Adults of either sex aged between 18 and 75 years of age
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Participants - exclusion criteria
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1. Pregnancy
2. Malignancy
3. Allergies to pantoprazole, amoxicillin, clarithromycin
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Anticipated start date
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01/12/2006
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Anticipated end date
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01/06/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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42
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Interventions
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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 measure(s)
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Eradication of Helicobacter pylori, measured at five weeks after the end of treatment.
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Secondary outcome measure(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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Sources of funding
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The Chios Mastic Gum Producers Cooperative (Greece)
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Trial website
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Publications
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Contact name
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Dr
Konstantinos
Dabos
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Address
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Helenas Venizelou 2
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City/town
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Chios
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Zip/Postcode
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821-00
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Country
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Greece
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Email
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kostasophia@yahoo.com
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Sponsor
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The Chios Mastic Gum Producers Cooperative (Greece)
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Address
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Konstantinou Monomahou 1
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City/town
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Chios
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Zip/Postcode
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821-00
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Country
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Greece
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Sponsor website:
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http://www.gummastic.gr
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Date applied
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31/03/2008
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Last edited
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29/04/2008
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Date ISRCTN assigned
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29/04/2008
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