Clinical trial NCT02072590: Improved Diagnostics of Celiac Disease in Children
Official title: Improved Diagnostics of Celiac Disease in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Eosinophilic Esophagitis
Keywords: Celiac disease
Eosinophilic esophagitis
Endomysial antibodies
Transglutaminase antibodies
Small-bowel
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
First posted: 2014-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital clinic; secondary and tertiary centers

Brief summary: 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Study refusal
* Age 18 years or more

Primary outcomes:
measure: Transglutaminase 2 antibodies
timeFrame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary outcomes:
measure: Serum endomysial antibodies
timeFrame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
measure: Visual Analog Scale
timeFrame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
measure: Dietary compliance
timeFrame: After 3 months, 6 months and 1 year on a gluten-free diet
measure: Height
timeFrame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
measure: Weight
timeFrame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
city: Bucharest
country: Romania
facility: University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Study officials:
affiliation: Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
name: Kalle Kurppa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurppa K, Ashorn M, Iltanen S, Koskinen LL, Saavalainen P, Koskinen O, Maki M, Kaukinen K. Celiac disease without villous atrophy in children: a prospective study. J Pediatr. 2010 Sep;157(3):373-80, 380.e1. doi: 10.1016/j.jpeds.2010.02.070. Epub 2010 Apr 18.
citation: Popp A, Mihu M, Munteanu M, Ene A, Dutescu M, Colcer F, Raducanu D, Laurila K, Anca I, Maki M. Prospective antibody case finding of coeliac disease in type-1 diabetes children: need of biopsy revisited. Acta Paediatr. 2013 Mar;102(3):e102-6. doi: 10.1111/apa.12117. Epub 2013 Jan 4.
citation: Taavela J, Koskinen O, Huhtala H, Lahdeaho ML, Popp A, Laurila K, Collin P, Kaukinen K, Kurppa K, Maki M. Validation of morphometric analyses of small-intestinal biopsy readouts in celiac disease. PLoS One. 2013 Oct 11;8(10):e76163. doi: 10.1371/journal.pone.0076163. eCollection 2013.
citation: Repo M, Lindfors K, Maki M, Huhtala H, Laurila K, Lahdeaho ML, Saavalainen P, Kaukinen K, Kurppa K. Anemia and Iron Deficiency in Children With Potential Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):56-62. doi: 10.1097/MPG.0000000000001234.
citation: Rajalahti T, Repo M, Kivela L, Huhtala H, Maki M, Kaukinen K, Lindfors K, Kurppa K. Anemia in Pediatric Celiac Disease: Association With Clinical and Histological Features and Response to Gluten-free Diet. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):e1-e6. doi: 10.1097/MPG.0000000000001221.