Celiac disease patients
Conditions
Interventions
Patients will consume 8 g wheat protein daily with AN-PEP enzyme for 14 d. After a 14-d washout period, patients who are negative for coeliac disease symptoms during the 1st period will randomly recei
Sponsors
DSM Food Specialties
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of coeliac disease (Marsh III B/C) ; that means crypt hyperplasia and subtotal or total villous atrophy, while using a normal diet followed by normalisation and clinical improvement on a gluten-free diet. 2. Detectable coeliac disease specific antibodies (EMA, tTGA) at time of diagnosis. 3. A strict gluten free diet for at least 1 year and normalised villous architecture (Marsh 0/I). 4. Male and female, 18-70 years old. 5. No detectable anti-endomysium and low anti-tissue transglutaminase (<4 U/ml) prior to the start of the study. 6. Patient is willing to undergo all protocol related assessments and visits (including up to 3 separate oesophago-gastro-duodenoscopies with multiple biopsies taken each time from the descending duodenum. 7. Patient has read the information provided on the study and given written consent; 8. Female participants at fertile age must use adequate contraception.
Exclusion criteria
Exclusion criteria: 1. Use of any immunoregulatory drug within the last 6 months 2. Use of any anticoagulant drug 3. Clinically suspected bleeding tendency 4. Pregnancy or breast feeding 5. Presence of any concurrent active infection 6. IgA deficiency 7. Use of medication within 8 hour prior to intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunohistopathological changes in small intestinal biopsies to diagnose coeliac disease | — |
Secondary
| Measure | Time frame |
|---|---|
| - Gluten reactive T cells - Coeliac disease specific antibodies - Coeliac disease-associated clinical symptoms (questionnaire) to diagnose coeliac disease | — |
Contacts
Public ContactC.J. Mulder
Department of Gastroenterology VUmc, Amsterdam P.O. Box 7057,
Outcome results
None listed