Effect of AN-PEP enzyme on gastrointestinal breakdown of immunogenic gluten epitopes in healthy subjects

Completed

• Conditions: celiac disease; gluten intolerance; 10017969; 10016950

• Registration Number: NL-OMON35905
• Lead Sponsor: DSM Food Specialties

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 17

Inclusion Criteria

Healthy;
Age >=18 but <45 yr
women; hormonal contraceptive therapy

Exclusion Criteria

Any medical condition that may interfere with the study and may jeopardise the health status of the participant
women; no use of hormonal contraceptive therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effect AN-PEP with a low or high caloric meal on duodenal gluten epitope<br /><br>exposure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Effect AN-PEP with a low or high caloric meal on<br /><br>gastric gluten epitope concentrations and AUC over time<br /><br>gastric and duodenal pH<br /><br>gastric half emptying time<br /><br>gastric and duodenal epitope concentrations or absolute amounts over<br /><br>time related to 3 and 4<br /><br>Difference in means between a low and high caloric meal with AN-PEP in all<br /><br>endpoints mentioned above</p><br>