Eradication of Helicobacter pylori increases ghrelin production in the gastric mucosa
| ISRCTN | ISRCTN59881192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59881192 |
| Protocol serial number | N/A |
| Sponsor | Inje University, Ilsan Paik Hospital (Korea, South) |
| Funder | Inje University, Ilsan paik Hospital (Korea, South) |
- Submission date
- 15/02/2008
- Registration date
- 10/03/2008
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eon Sook Lee
Scientific
Scientific
2240
Daewha-dong
Ilsanseo-gu
Goyang-si
Gyeonggi-do
411-706
Korea, South
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate whether Helicobacter pylori eradication influences ghrelin/obestatin production and appetite. |
| Ethics approval(s) | Institutional Review Board of Inje University, Ilsan-Paik Hospital, Clinical Research Center 05-12, South Korea. Date of approval: 28/10/2005 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | esomeprazole, amoxicillin, and clarithromycin |
| Primary outcome measure(s) |
Ghrelin mRNA levels in gastric mucosa at baseline and 5 weeks |
| Key secondary outcome measure(s) |
The following were assessed at baseline and 5 weeks: |
| Completion date | 30/05/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Healthy volunteers with H. pylori infection, who saw a poster describing the study and wanted to participate. |
| Key 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 |
| Date of first enrolment | 17/02/2006 |
| Date of final enrolment | 30/05/2006 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
2240
Gyeonggi-do
411-706
Korea, South
411-706
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
