Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To investigate whether Helicobacter pylori eradication influences ghrelin/obestatin production and appetite.
Ethics approval
Institutional Review Board of Inje University, Ilsan-Paik Hospital, Clinical Research Center 05-12, South Korea. Date of approval: 28/10/2005
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Helicobacter pylori infection
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
esomeprazole, amoxicillin, and clarithromycin
Primary outcome measures
Ghrelin mRNA levels in gastric mucosa at baseline and 5 weeks
Secondary outcome measures
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
Overall trial start date
17/02/2006
Overall trial end date
30/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy volunteers with H. pylori infection, who saw a poster describing the study and wanted to participate.
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
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
Recruitment start date
17/02/2006
Recruitment end date
30/05/2006
Locations
Countries of recruitment
Korea, South
Trial participating centre
2240
Gyeonggi-do
411-706
Korea, South
Sponsor information
Organisation
Inje University, Ilsan Paik Hospital (Korea, South)
Sponsor details
2240
Daewha-dong
Ilsanseo-gu
Goyang-si
Gyeonggi-do
411-706
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Inje University, Ilsan paik Hospital (Korea, South)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary