The primary oblective of the study is to elucidate all molecular mechanisms leading to coeliac disease.In order to establish the scientific basis for the development of improved diagnostics, novel therapies and safer foods for patients, in the CDC:…
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
- Malabsorption conditions
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of (aberrant) molecular pathways leading to disease development.
Safer foods for coeliac patients
Gluten digesting drugs
Secondary outcome
Not applicable
Background summary
Dutch celiac disease researchers in the Leiden University Medical Center, the
University Medical Center Utrecht, TNO Quality of Life and the Wageningen
University have joined forces in a research project called the Celiac Disease
Consortium (CDC). The CDC is co-ordinated by the LUMC and funded by the Dutch
government.
As celiac disease is a disease that is exclusively found in humans, this
research depends on the ongoing availability of patient derived materials. Such
material can be obtained through routine diagnostic procedures, like venous
blood sampling and the sampling of intestinal biopsies during diagnostic
endoscopy.
Through this protocol we ask for continued permission to obtain 10 ml extra of
venous blood and 4 extra duodenal biopsies, through asking informed consent to
sample extra patient material in all consecutive children that undergo upper
gastrointestinal endoscopy as a part of their individual diagnostic workup in
the LUMC.
Study objective
The primary oblective of the study is to elucidate all molecular mechanisms
leading to coeliac disease.
In order to establish the scientific basis for the development of improved
diagnostics, novel therapies and safer foods for patients, in the CDC:
A Human Genomics research cluster will focus on the identification of
(aberrant) molecular pathways leading to disease development.
A Food Genomics research cluster will concentrate on reduction of gluten
intake.
Study design
In the CDC, the patient derived materials will be used within the framework of
teh Human Genomics Cluster to perform:
Functional studies of T-cell lines isolated from intestinl biopsies
Changes in protein expression patterns derived from intesitinal biopsies
Genetic studies in DNA isolated from blood lymphocytes and in mRNA isolated
from intestinal biopsies.
Study burden and risks
From each patient, 4 extra duodenal biopsies and 10 ml of venous blood will be
obtained. It is emphasized that in all cases the children undergo endoscopy as
a workup for upper gastro-intestinal disease and not for the purpose of
scientifc research. Since the endoscopy in children is routinely performed
under general anesthesia, for which intravenous catheterization is mandatory,
blood samples and biopsies can be drawn during anesthesia without extra burden
or risk to the patients.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
1. All children that undergo upper gastrointestinal endoscopy in the Willem-Alexander Kinder-en Jeugd Centrum of the Leiden University Medical Center are eligible for the study.;2. Informed consent.
Exclusion criteria
1. Increased risk for bleeding or perforation.
2. No informed consent.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13313.058.06 |