Eradication of Helicobacter pylori increases ghrelin production in the gastric mucosa
| ISRCTN | ISRCTN59881192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59881192 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | esomeprazole, amoxicillin, and clarithromycin |
| Primary outcome measure | 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 study start date | 17/02/2006 |
| Completion date | 30/05/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Inje University, Ilsan Paik Hospital (Korea, South)
University/education
University/education
2240
Daewha-dong
Ilsanseo-gu
Goyang-si
Gyeonggi-do
411-706
Korea, South
| Website | http://www.inje.ac.kr/english |
|---|---|
"ROR" |
https://ror.org/01zx5ww52 |
Funders
Funder type
University/education
Inje University, Ilsan paik Hospital (Korea, South)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
