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Impact of the Diagnosis of Celiac Disease

Impact of the Diagnosis of Celiac Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01145287
Enrollment
760
Registered
2010-06-16
Start date
2007-02-28
Completion date
2016-04-30
Last updated
2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac disease, Gluten-free diet, Screen-detected, Asymptomatic, Quality of life, Self-perceived health, Healthcare resource utilization

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Tampere University
CollaboratorOTHER
Finnish Celiac Society
CollaboratorUNKNOWN
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* diagnosis within one year * biopsy-proven diagnosis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Psychological General Well-Being (PGWB) Index5 yearsHealth-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Secondary

MeasureTime frameDescription
Gastrointestinal Symptoms Rating Scale (GSRS)5 yearsclinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
dietary compliance5 yearsself-assessed compliance to the dietary treatment
healthcare resource utilization5 yearsHealthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents
height5 yearseffect of the dietary treatment in the height of children with celiac disease
The Short Form (SF-36) Health Survey5 yearsHealth-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
weight5 yearseffect of the dietary treatment in the weight of celiac disease patients

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026