Aim: To investigate the performance of the new ESPGHAN diagnostic criteria for celiac disease in practice in different European countries.Primary aim: To evaluate whether the omission of biopsies in selected pediatric cases does result in certain…
ID
Source
Brief title
Condition
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate whether the omission of biopsies in selected pediatric cases does
result in certain diagnosis of celiac disease (avoid false positive diagnosis
of celiac disease).
Secondary outcome
- To evaluate characteristics and severity of symptoms in relation to histology
and celiac disease specific antibody titers.
- To determine the best optimal cut-off point for antibody levels in children
with symptoms of celiac disease which predict mucosal damge with 99%
specificity.
- To determine whether the determination of HLA typing adds diagnostic value in
cases with positive specific antibodies.
- To determine which of the available antibody tests (TG2, EMA, DGP) are most
suitable for the initial diagnosis in relation to age and type of symptoms.
Background summary
Celiac disease is a frequently diagnosed chronic disease of the small bowel.
Gluten causes mucosal damage of the small intestine. Gluten is present in the
following grains: wheat, barley, and rye and almost any foods made therefrom.
Undiagnosed and/or untreated celiac disease gives a severity of clinical
symptoms. Celiac disease is treated by a gluten free diet (GFD). A GFD is not
easy to follow and it can affect quality of life (QoL). Small bowel biopsies
have so far been considered as the reference standard for the diagnosis of
celiac disease. However, during the last decades evidence has accumulated on
the diagnostic value of specific celiac disease antibodies, and HLA typing has
increasingly been used for diagnostic purposes. At the same time, the leading
role of histology for the diagnosis of CD has been questioned.
Therefore new diagnostic guidelines/criteria for CD were developed by the
ESPGHAN working group. This current study investigates the performance of the
new ESPGHAN diagnostic criteria for celiac disease in practice in different
European countries and especially evaluates whether the omission of biopsies in
selected pediatric cases does result in certain diagnosis of celiac disease
(avoid false positive diagnosis of celiac disease).
Study objective
Aim: To investigate the performance of the new ESPGHAN diagnostic criteria for
celiac disease in practice in different European countries.
Primary aim: To evaluate whether the omission of biopsies in selected pediatric
cases does result in certain diagnosis of celiac disease (avoid false positive
diagnosis of celiac disease).
Secondary aims:
- To evaluate characteristics and severity of symptoms in relation to histology
and celiac disease specific antibody titers.
- To determine the best optimal cut-off point for antibody levels in children
with symptoms of celiac disease which predict mucosal damge with 99%
specificity.
- To determine whether the determination of HLA typing adds diagnostic value in
cases with positive specific antibodies.
- To determine which of the available antibody tests (TG2, EMA, DGP) are most
suitable for the initial diagnosis in relation to age and type of symptoms.
Study design
Prospective multicenter observation study in 600 children with suspected celiac
disease who will be diagnosed based on serology and duodenal biopsies plus in
addition more extensive serology, HLA testing, and standardized symptom
assessment. The children wiil be followed for 18 months after diagnosis.
Study burden and risks
The study takes minimal extra time above the normal diagnostic procedure.
- During the follow up visits, besides the medical history, physical
examination and collection of blood, a standardized questionnaire will be
filled on clinical symptoms and adherence to gluten free diet.
- Duodenal biopsies will be taken to diagnose celiac disease.
Risks for the participants:
- risk of anesthesia
- risk of endoscopy: bleeding
Both risks are very low, and so far small bowel biopsies have been considered
as the reference standard for the diagnosis of celiac disease.
In our hospital, we didn't see any of the risks/complications described
above.
Dunford Mill .
Hampshire GU31 5AZ
GB
Dunford Mill .
Hampshire GU31 5AZ
GB
Listed location countries
Age
Inclusion criteria
Consecutive children (age > 6 months - < 18.0 years) with a high degree suspicion for celiac disease consuming a gluten containing diet:
- A child with clinical symptoms indicative of celiac disease plus a positive test of any titer specific height for celiac disease specific antibodies (TG2, EMA, DGP- cave positive DGP-titer alone does not quanlify the patient for biopsy!) or
- A child with an increased risk for celiac disease such as having relatives of celiac disease patients or patients with diseases associated with celiac disease (Hashimoto Thyroiditis, Type I DM, Down's symdrome) with no or mild unspecific clinical symptoms but with a positive test for celiac disease specific antibodies (positive test for TG2 and/or positive EMA (>1:10)).
Exclusion criteria
- Patient with symptoms that may indicate celiac disease, but negative celiac disease specific antibodies (TG2 or EMA), but normal IgA.
- Patient without symptoms, and negative celiac specific antibodies (TG2 and EMA)
- Malignancy
- Serious chronic infections such as HIV or tuberculosis or congenital immunodeficiency
- Contraindications for endoscopy/biopsies
- Parents did not sign consent form
- Parents can not read/are not able to understand to give informed consent
Design
Recruitment
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| Other | DRKS00003555 |
| CCMO | NL40200.058.12 |