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Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals

NCT02060864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-08-28

No results posted yet for this study

Summary

In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.

Conditions

  • Non-coeliac Gluten Sensitivity

Interventions

DIETARY_SUPPLEMENT

AN-PEP

Two pills are consumed in the morning with a breakfast

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • DSM Food Specialties

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02060864 on ClinicalTrials.gov