Effect of AN-PEP enzyme on gluten digestion.

• Conditions: Healthy subjects. Intended target population; gluten intolerant/sensitive people

• Registration Number: NL-OMON21404
• Lead Sponsor: Dr Maaike BruinsDSM Biotechnology CentreAlexander Fleminglaan 12613 AX Delft, The Netherlands+31 15 2792056Maaike.Bruins@DSM.com

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Male/female;

2. Age ≥18 but <45 yr;

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect AN-PEP with a low or high caloric meal on duodenal gluten epitope exposure.

Secondary Outcome Measures

Name	Time	Method
Effect AN-PEP with a low or high caloric meal on:<br /><br>1. Gastric gluten concentrations and AUC over time;<br /><br>2. Gastric and duodenal pH;<br /><br>3. Gastric half emptying time;<br /><br>4. Gastric and duodenal gluten concentrations or absolute amounts over time related to 3 and 4.<br><br /><br /><br>Difference in means between a low and high caloric meal with AN-PEP in:<br /><br>1. All endpoints mentioned above.