A population based randomised controlled trial of Helicobacter pylori eradication: impact on dyspepsia, quality of life and health
| ISRCTN | ISRCTN44816925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44816925 |
| Secondary identifying numbers | LIP/H2B/001 |
- Submission date
- 03/08/2006
- Registration date
- 29/08/2006
- Last edited
- 23/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Athene Lane
Scientific
Scientific
University of Bristol
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HEALTH |
| Study objectives | To determine the impact of a community-based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use and Quality of Life (QoL), including a cost-consequences analysis. |
| Ethics approval(s) | Gained ethics approval from Frenchay Hospital LREC (reference number: 95/83 20/01/1996). |
| Health condition(s) or problem(s) studied | Dyspepsia |
| Intervention | Subjects were screened for H. pylori. Those who were positive were randomised between active eradication therapy or a placebo. Subjects were not randomised if they were found to be uninfected with H. pylori. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Helicobacter pylori |
| Primary outcome measure | Dyspepsia resolution at two years after randomisation. |
| Secondary outcome measures | 1. Reduction in health service utilisation 2. Quality of life |
| Overall study start date | 01/05/1996 |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1550 |
| Key inclusion criteria | 1. Aged 20 to 59 years, male and female 2. Able to give written informed consent |
| Key exclusion criteria | Any persons with the following conditions: pregnancy, breast feeding, severe renal impairment, adverse reaction to macrolide antibiotics, concurrent medication with wafarin, theophyllin, digoxin, terfendine, carbemazepine, ergot derivatives, bismuth compounds, acute porphyria. |
| Date of first enrolment | 01/05/1996 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Bristol
Bristol
BS8 2PR
United Kingdom
BS8 2PR
United Kingdom
Sponsor information
NHS (South and West) (UK)
Government
Government
Westward House
Lime Kiln Close
Stoke Gifford
Bristol
BS12 6SR
United Kingdom
| Website | http://www.bristolswpct.nhs.uk/ |
|---|
Funders
Funder type
Government
NHS Executive (south and west)
No information available
Glaxo Wellcome UK
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results: | 12/06/2004 | Yes | No | |
| Results article | results: | 28/01/2006 | Yes | No | |
| Results article | results: | 15/04/2008 | Yes | No |
