Improved Diagnostics of Celiac Disease in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Tampere University Hospital
Sponsor:
Collaborator:
Carol Davila University of Medicine and Pharmacy
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT02072590
First received: February 20, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.


Condition
Celiac Disease
Eosinophilic Esophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Diagnostics of Celiac Disease in Children

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Transglutaminase 2 antibodies [ Time Frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Change of the transglutaminase 2 antibody levels on a gluten-free diet


Secondary Outcome Measures:
  • Serum endomysial antibodies [ Time Frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Change of the endomysial antibody levels on a gluten-free diet

  • Visual Analog Scale [ Time Frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Change in the the subjective perception of health measured by Visual Analog Scale

  • Dietary compliance [ Time Frame: After 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Adherence to the gluten-free diet

  • Height [ Time Frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Change of height (centimeters) on a gluten-free diet

  • Weight [ Time Frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet ] [ Designated as safety issue: No ]
    Change of weight (kilograms) on a gluten-free diet


Biospecimen Retention:   Samples With DNA

Whole blood, serum, intestinal mucosal biopsies


Estimated Enrollment: 2000
Study Start Date: August 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Detailed Description:

Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital clinic; secondary and tertiary centers

Criteria

Inclusion Criteria:

  • Suspicion of celiac disease or gluten sensitivity
  • Age below 18 years

Exclusion Criteria:

  • Study refusal
  • Age 18 years or more
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072590

Contacts
Contact: Kalle Kurppa, MD kalle.kurppa@uta.fi

Locations
Finland
Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital Recruiting
Tampere, Finland, 33520
Contact: Kalle Kurppa, MD       kalle.kurppa@uta.fi   
Principal Investigator: Kalle Kurppa, MD         
Romania
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania Recruiting
Bucharest, Romania
Contact: Alina Popp, MD       alina.popp@uta.fi   
Sponsors and Collaborators
Tampere University Hospital
Carol Davila University of Medicine and Pharmacy
Investigators
Principal Investigator: Kalle Kurppa, MD Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
  More Information

Publications:
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02072590     History of Changes
Other Study ID Numbers: R11187
Study First Received: February 20, 2014
Last Updated: February 28, 2014
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Tampere University Hospital:
Celiac disease
Eosinophilic esophagitis
Endomysial antibodies
Transglutaminase antibodies
Small-bowel

Additional relevant MeSH terms:
Celiac Disease
Esophagitis
Eosinophilic Esophagitis
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Esophageal Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014