Improved Diagnostics of Celiac Disease in Children

Celiac Disease Clinical Trial

Official title:

Improved Diagnostics of Celiac Disease in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072590
• Other study ID #: R11187
• Status: Completed
• Start date: August 2011
• Est. completion date: November 21, 2023

Study information

• Verified date: November 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Study refusal
• Age 18 years or more

Related Conditions & MeSH terms

• Celiac Disease
• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
Finland	Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital	Tampere
Romania	University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Carol Davila University of Medicine and Pharmacy

Countries where clinical trial is conducted

Finland,  Romania, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transglutaminase 2 antibodies	Change of the transglutaminase 2 antibody levels on a gluten-free diet	Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary	Serum endomysial antibodies	Change of the endomysial antibody levels on a gluten-free diet	Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary	Visual Analog Scale	Change in the the subjective perception of health measured by Visual Analog Scale	Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary	Dietary compliance	Adherence to the gluten-free diet	After 3 months, 6 months and 1 year on a gluten-free diet
Secondary	Height	Change of height (centimeters) on a gluten-free diet	Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary	Weight	Change of weight (kilograms) on a gluten-free diet	Baseline and after 3 months, 6 months and 1 year on a gluten-free diet