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HEP-FYN 12-Years Follow-up

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ClinicalTrials.gov Identifier: NCT02001727
Recruitment Status : Unknown
Verified November 2014 by Maria Bomme, Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2013
Last Update Posted : November 20, 2014
Sponsor:
Collaborators:
Region of Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Maria Bomme, Odense University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Peptic Ulcer Dyspepsia Reflux Other: 13C-Urea breath test for Helicobacter Pylori Other: Questionaire Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
Study Start Date : March 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hp-screened group
Screened for Helicobacter Pylori and eradication therapy (1998-99)
Other: Questionaire
Control group
primarily unscreened group
Other: 13C-Urea breath test for Helicobacter Pylori
Other: Questionaire



Primary Outcome Measures :
  1. Economic Evaluation [ Time Frame: twelve years ]

    The overall endpoint is expenditure in Danish kroner (on ulcer drugs, upper gastrointestinal endoscopy, GP consultations, hospital admissions related to peptic ulcer).

    Data on resource consumption of these services and procedures is multiplied with relevant unit prices, from the Danish Medicines Agency and the Danish National Board of Health, to assess a health-cost endpoint.



Secondary Outcome Measures :
  1. Frequency of symptoms (dyspepsia, reflux) [ Time Frame: twelve years ]
  2. Drug consumption [ Time Frame: Twelve years ]
    Consumption of ulcer drugs including over the counter drugs

  3. Quality of life [ Time Frame: twelve years ]
  4. Incidence of esophagus- and gastric cancer [ Time Frame: Twelve years ]
  5. Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle. [ Time Frame: Twelve Years ]
  6. Frequency of peptic ulcers incl. complicated ulcers [ Time Frame: Twelve years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Bomme, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02001727     History of Changes
Other Study ID Numbers: s-20110054-97/262
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Peptic Ulcer
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases