Overview

This trial is active, not recruiting.

Conditions peptic ulcer, dyspepsia, reflux
Treatments 13c-urea breath test for helicobacter pylori, questionaire
Sponsor Odense University Hospital
Collaborator Region Southern Denmark
Start date March 2012
End date February 2015
Trial size 10000 participants
Trial identifier NCT02001727, s-20110054-97/262

Summary

Aims:

1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia related health-care consumption and quality of life.

2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination of these conditions and the effect on quality of life, prognosis and dyspepsia-related health care expenditure.

Methods:

In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration number, were allocated by a computerized randomized procedure to HP-screening group and control group. All participants received a questionnaire at inclusion, 1-year and 5-year and now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In addition we will obtain information from registers on, comorbidity, use of endoscopies and prescription medication. An economic evaluation is done alongside the randomized trial.

The primary unscreened group is invited to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status

Expected results:

The study will provide information on the long-term effect of HP-screening and eradication in a population. The study will provide information about the long-term effect on incidence of peptic ulcer in an aging population that is likely to have an increased consumption of ASA and NSAID. Furthermore the study will generate knowledge about the long-term prognosis of dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from the 5-yr follow-up (13) showed that is has a great influence on quality of life and the dyspepsia-related health care consumption, whether the individual has solely reflux, solely dyspepsia or a combination of both symptoms.

Long-term follow-up and further analyses of these findings could have great impact on management and treatment of individuals with symptoms. It is important to focus on groups; in which the symptoms have the greatest influence on quality of life of the individual. This finding has not been displayed in other studies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Screened for Helicobacter Pylori and eradication therapy (1998-99)
questionaire
(Other)
primarily unscreened group
13c-urea breath test for helicobacter pylori
questionaire

Primary Outcomes

Measure
Economic Evaluation
time frame: twelve years

Secondary Outcomes

Measure
Frequency of symptoms (dyspepsia, reflux)
time frame: twelve years
Drug consumption
time frame: Twelve years
Quality of life
time frame: twelve years
Incidence of esophagus- and gastric cancer
time frame: Twelve years
Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle.
time frame: Twelve Years
Frequency of peptic ulcers incl. complicated ulcers
time frame: Twelve years

Eligibility Criteria

Male or female participants from 52 years up to 75 years old.

Inclusion Criteria: - Individuals participating in 5 year follow-up Exclusion Criteria: - Individuals not participating in 5 year follow-up - Moved outside the Region of Southern Denmark or with an unknown address - Individuals who died

Additional Information

Official title Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
Description Questionnaire: Information on abdominal symptoms (GRSR: Gastrointestinal symptom rating scale, rate of symptoms, quality of life (SF-36, EQ-5D-5L), consumption of ulcer drugs including over the counter drugs, hospital admissions, dyspepsia-related sick leave days, consultations and comorbidity). A reminder is sent out 2 weeks after the first contact. Register data: OPED (Odense Pharmaca-epidemiological Database): Information on reimbursable ulcer drugs, ASA, NSAID and HP-eradication therapy. The Regional Hospital discharge Register: Information based on International Classification of Diseases (ICD). Information on ulcer-related admissions, out-patient ulcer diagnosis and comorbidity, use of upper gastrointestinal endoscopy. HP-test unscreened group: Invitation of the primary unscreened group to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status. Instruments: automated breath 13Co2 analyser- Isotope ratio mass spectrometer. Almost all persons are infected with HP during childhood. Infection with the bacteria in adulthood is rare. Only few persons spontaneously turn HP-negative. From OPED we will know which individuals who have been prescribed HP-eradication treatment. Thus the participants in the control group, who are HP-positive at 12-yr follow-up, have had the infection the whole period. Provided they have not received HP-eradication treatment, those who are tested HP-negative have been so the whole period.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Odense University Hospital.