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ISRCTN
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ISRCTN59881192
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ClinicalTrials.gov identifier
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Public title
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Eradication of Helicobacter pylori increases ghrelin production in the gastric mucosa
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To investigate whether Helicobacter pylori eradication influences ghrelin/obestatin production and appetite.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Institutional Review Board of Inje University, Ilsan-Paik Hospital, Clinical Research Center 05-12, South Korea. Date of approval: 28/10/2005
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Study design
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Randomised controlled trial
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Countries of recruitment
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Korea, South
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Disease/condition/study domain
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Helicobacter pylori infection
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Participants - inclusion criteria
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Healthy volunteers with H. pylori infection, who saw a poster describing the study and wanted to participate.
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Participants - exclusion criteria
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1. Age <20 or >70 years
2. Pregnancy
3. Abnormal gastric lesion, including ulcer and cancer
4. Duodenal ulcer
5. Liver disease
6. Renal impairment
7. Previous gastrointestinal surgery
8. History of H. pylori eradication
9. Drug abuse
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Anticipated start date
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17/02/2006
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Anticipated end date
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30/05/2006
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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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30
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Interventions
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The treatment group received a triple H. pylori eradication regimen consisting of 20 mg esomeprazole, 1,000 mg amoxicillin and 500 mg clarithromycin, twice daily for 7 days. The control group received no medication.
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Primary outcome measure(s)
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Ghrelin mRNA levels in gastric mucosa at baseline and 5 weeks
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Secondary outcome measure(s)
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The following were assessed at baseline and 5 weeks:
1. Obestatin and TNF-a mRNA of gastric mucosa
2. Plasma ghrelin, obestatin and ghrelin/obestatin ratio
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Sources of funding
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Inje University, Ilsan paik Hospital (Korea, South)
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Trial website
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Publications
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Contact name
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Dr
Eon Sook
Lee
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Address
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2240
Daewha-dong
Ilsanseo-gu
Goyang-si
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City/town
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Gyeonggi-do
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Zip/Postcode
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411-706
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Country
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Korea, South
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Sponsor
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Inje University, Ilsan Paik Hospital (Korea, South)
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Address
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2240
Daewha-dong
Ilsanseo-gu
Goyang-si
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City/town
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Gyeonggi-do
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Zip/Postcode
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411-706
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Country
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Korea, South
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Sponsor website:
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http://www.inje.ac.kr/english
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Date applied
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15/02/2008
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Last edited
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16/08/2011
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Date ISRCTN assigned
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10/03/2008
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