Improved Diagnostics of Celiac Disease in Children

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02072590
Study type	Observational
Source	Tampere University Hospital
Contact
Status	Completed
Phase
Start date	August 2011
Completion date	November 21, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04349904` - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT05810441` - Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis
Recruiting	`NCT05555446` - Bovine Colostrum to Prevent Absorption of Gluten	Early Phase 1
Completed	`NCT02754609` - Hookworm Therapy for Coeliac Disease	Phase 1
Terminated	`NCT01902368` - Celiac Disease Screening	N/A
Completed	`NCT02472704` - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo	N/A
Completed	`NCT02312349` - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Completed	`NCT01172665` - Celiac Disease Database
Completed	`NCT01100099` - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease	Phase 2/Phase 3
Completed	`NCT00639444` - Risk of Celiac Disease and Age at Gluten Introduction	N/A
Active, not recruiting	`NCT05425446` - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients	Phase 1
Enrolling by invitation	`NCT02202681` - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule	N/A
Completed	`NCT00362856` - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects	Phase 2
Terminated	`NCT03866538` - Budesonide in Patients With Immune Mediated Enteropathies	Phase 4
Recruiting	`NCT05135923` - Glutenfree, Gut Microbiota and Metabolic Regulation	N/A
Completed	`NCT05052164` - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women	N/A
Completed	`NCT03775499` - Probiotic BL NCC 2705 and Gluten Sensitivity	N/A
Completed	`NCT03707730` - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease	Phase 2