Improved Diagnostics of Celiac Disease in Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Celiac Disease; Eosinophilic Esophagitis

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
• Romania
  • Bucharest, Romania
    • University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital clinic; secondary and tertiary centers

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Study refusal
• Age 18 years or more

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Dietary compliance	Adherence to the gluten-free diet	After 3 months, 6 months and 1 year on a gluten-free diet
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
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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (ESTIMATE): February 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Eosinophilic esophagitis; Celiac disease; Endomysial antibodies; Transglutaminase antibodies; Small-bowel
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Malabsorption Syndromes; Eosinophilia; Celiac Disease; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: R11187