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OpenTrials
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NCT Number: NCT01145287

Impact of the Diagnosis of Celiac Disease

The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Research Centre, University of Tampere, Tampere University Hospital

Tampere, Pirkanmaa, 33014, Finland

About this study

All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis within one year
  • biopsy-proven diagnosis

Exclusion criteria

  • Celiac disease diagnosis previously than within one year
  • No biopsy-proven diagnosis

Treatment and study plan

Primary outcomes

  1. Psychological General Well-Being (PGWB) Index

    Time frame: 5 years

    Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Secondary outcomes

  1. healthcare resource utilization

    Time frame: 5 years

    Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents

  2. Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: 5 years

    clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

  3. dietary compliance

    Time frame: 5 years

    self-assessed compliance to the dietary treatment

  4. weight

    Time frame: 5 years

    effect of the dietary treatment in the weight of celiac disease patients

  5. height

    Time frame: 5 years

    effect of the dietary treatment in the height of children with celiac disease

  6. The Short Form (SF-36) Health Survey

    Time frame: 5 years

    Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Finnish Celiac Society
  • Tampere University

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2010
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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