Healthy subjects. Intended target population
Conditions
Interventions
All subjects will come to the study site for 4 test days. A gastro-duodenal catheter will be placed in the stomach and duodenum under x-ray control.
At these test days, in a crossover fashion, all su
2. A high caloric gluten meal together with AN-PEP drink
3. A low caloric gluten meal together with placebo drink
4. A high caloric gluten meal together with placebo drink.
The subjects will be randomised before start in a double-blind fashion in blocks of four. Meals contain 5.2 g gluten powder (4 g gluten pro
Sponsors
Dr Maaike Bruins
DSM Biotechnology Centre
Alexander Fleminglaan 1
2613 AX Delft, The Netherlands
+31 15 2792056
Maaike.Bruins@DSM.com
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/female; 2. Age ≥18 but <45 yr; 3. Hormonal contraceptive treatment; 4. Subject is willing to undergo all protocol related assessments; 5. Subject has read and understood the information provided on the study and given written informed consent.
Exclusion criteria
Exclusion criteria: Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect AN-PEP with a low or high caloric meal on duodenal gluten epitope exposure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect AN-PEP with a low or high caloric meal on: 1. Gastric gluten concentrations and AUC over time; 2. Gastric and duodenal pH; 3. Gastric half emptying time; 4. Gastric and duodenal gluten concentrations or absolute amounts over time related to 3 and 4. Difference in means between a low and high caloric meal with AN-PEP in: 1. All endpoints mentioned above. | — |
Contacts
Public ContactAd Masclee
Maastricht University Medical Center, Department of Internal Medicine, Division of Gastroenterology-Hepatology P.O. Box 5800
Outcome results
None listed