Condition category
Infections and Infestations
Date applied
15/02/2008
Date assigned
10/03/2008
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eon Sook Lee

ORCID ID

Contact details

2240
Daewha-dong
Ilsanseo-gu
Goyang-si
Gyeonggi-do
411-706
Korea
South

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

http://www.inje.ac.kr/english

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

Publication citations

Additional files

Editorial Notes