AN-PEP helps to digest gluten in vivo.
Bron
Verkorte titel
Aandoening
Healthy subjects. Intended target population; gluten intolerant/sensitive people
Ondersteuning
DSM Biotechnology Centre
Alexander Fleminglaan 1
2613 AX Delft, The Netherlands
+31 15 2792056
Maaike.Bruins@DSM.com
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Effect AN-PEP with a low or high caloric meal on duodenal gluten epitope exposure.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
AN-PEP helps to digest gluten in vivo.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL2652 |
NTR-old | NTR2780 |
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