No registrations found.
ID
Source
Brief title
Health condition
Healthy subjects. Intended target population; gluten intolerant/sensitive people
Sponsors and support
DSM Biotechnology Centre
Alexander Fleminglaan 1
2613 AX Delft, The Netherlands
+31 15 2792056
Maaike.Bruins@DSM.com
Intervention
Outcome measures
Primary outcome
Effect AN-PEP with a low or high caloric meal on duodenal gluten epitope exposure.
Secondary outcome
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.
Background summary
In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.
Study objective
AN-PEP helps to digest gluten in vivo.
Study design
N/A
Intervention
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 subjects receive enterally via this catheter one of the following treatments:
1. A low caloric gluten meal together with AN-PEP drink;
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 protein) which is mixed in all test meals (300 mL). The low and high caloric meals differ in fat and carbohydrate. The meal is co-infused with AN-PEP or placebo in 50 mL water. Stable 13C-octanoic acid is added to the meals to measure gastric emptying rate.
Department of Internal Medicine, Division of Gastroenterology-Hepatology
P.O. Box 5800
Ad Masclee
Debeijeplein 25
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875021
a.masclee@mumc.nl
Department of Internal Medicine, Division of Gastroenterology-Hepatology
P.O. Box 5800
Ad Masclee
Debeijeplein 25
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3875021
a.masclee@mumc.nl
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
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
Recruitment
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 |
|---|---|
| NTR-new | NL2652 |
| NTR-old | NTR2780 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |