Condition category
Digestive System
Date applied
03/08/2006
Date assigned
29/08/2006
Last edited
23/04/2008
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 Athene Lane

ORCID ID

Contact details

University of Bristol
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LIP/H2B/001

Study information

Scientific title

Acronym

HEALTH

Study hypothesis

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

Gained ethics approval from Frenchay Hospital LREC (reference number: 95/83 20/01/1996).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Helicobacter pylori

Primary outcome measures

Dyspepsia resolution at two years after randomisation.

Secondary outcome measures

1. Reduction in health service utilisation
2. Quality of life

Overall trial start date

01/05/1996

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 20 to 59 years, male and female
2. Able to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1550

Participant 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.

Recruitment start date

01/05/1996

Recruitment end date

01/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

NHS (South and West) (UK)

Sponsor details

Westward House
Lime Kiln Close
Stoke Gifford
Bristol
BS12 6SR
United Kingdom

Sponsor type

Government

Website

http://www.bristolswpct.nhs.uk/

Funders

Funder type

Government

Funder name

NHS Executive (south and west)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Glaxo Wellcome UK

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

1. 2004 results: http://www.ncbi.nlm.nih.gov/pubmed/15126313
2. 2006 results: http://www.ncbi.nlm.nih.gov/pubmed/16428249
3. 2008 results: http://www.ncbi.nlm.nih.gov/pubmed/18412958

Publication citations

  1. Results

    Harvey RF, Lane JA, Murray LJ, Harvey IM, Donovan JL, Nair P, , Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter project., BMJ, 2004, 328, 7453, 1417, doi: 10.1136/bmj.38082.626725.EE.

  2. Results

    Murray LJ, McCarron P, McCorry RB, Anderson LA, Lane AJ, Johnston BT, Smith GD, Harvey RF, Inverse association between gastroesophageal reflux and blood pressure: results of a large community based study., BMC Gastroenterol, 2008, 8, 10, doi: 10.1186/1471-230X-8-10.

  3. Lane JA, Murray LJ, Noble S, Egger M, Harvey IM, Donovan JL, Nair P, Harvey RF, Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial., BMJ, 2006, 332, 7535, 199-204, doi: 10.1136/bmj.38702.662546.55.

Additional files

Editorial Notes