Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals (AN-PEP-03)

August 27, 2015 updated by: Robert Brummer, DSM Food Specialties

Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 701 82
        • Örebro University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/female
  • Age ≥18 but <70 yr
  • Females: Hormonal contraceptive treatment
  • Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
  • Subject has read and understood the information provided on the study and given written informed consent

Exclusion Criteria:

  • Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
  • Wheat allergy (serological test for wheat protein IgE antibodies)
  • Medication or medical condition that affects gastric emptying or secretion
  • Females: Pregnancy or breast-feeding
  • Inability to swallow the gastroduodenal feeding tube
  • Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
  • Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 Placebo pills
Dietary supplement: Placebo
Experimental: AN-PEP 80.000 PPI
1 pill AN-PEP 80.000 PPI and 1 pill Placebo.
Dietary supplement: AN-PEP
Two pills are consumed in the morning with a breakfast
Other Names:
  • Aspergillus Niger-Prolyl Endopeptidase
Experimental: AN-PEP 160.000 PPI
2 pills AN-PEP 80.000 PPI
Dietary supplement: AN-PEP
Two pills are consumed in the morning with a breakfast
Other Names:
  • Aspergillus Niger-Prolyl Endopeptidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of 160.000 PPI AN-PEP on duodenal gluten
Time Frame: 3-hour
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
3-hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of 160.000 PPI AN-PEP on gastric gluten
Time Frame: 3-hour
Effect of AN-PEP (160.000 PPI) on gluten degradation based on amount of gluten detected in the stomach compared with placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
3-hour
Effect of 80.000 PPI AN-PEP on duodenal gluten
Time Frame: 3-hour
Effect of AN-PEP (80.000 PPI) on gluten degradation based on amount of gluten detected in the duodenum compared to placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
3-hour
Effect of 80.000 PPI AN-PEP on gastric gluten AUC
Time Frame: 3-hour
Effect of AN-PEP (80.000 PPI) on gluten degradation based on amount of gluten detected in the stomach compared to placebo over 180 min (Success is defined as at least 50% gluten degradation compared to placebo in an individual test, calculated using AUC)
3-hour
Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
Time Frame: 3-hour
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (160.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the duodenum compared with placebo over 180 min using AUC.
3-hour
Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
Time Frame: 3-hour
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (160.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the stomach compared with placebo over 180 min using AUC.
3-hour
Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
Time Frame: 3-hour
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (80.000 PPI) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the duodenum compared with placebo over 180 min using AUC.
3-hour
Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
Time Frame: 3-hour
The average reduction in gluten concentration (as a continuous measure) following administration of AN-PEP (low and high dose) on gluten degradation (defined as the percentage of gluten degraded by 180 minutes) based on gluten detection in the stomach compared with placebo over 180 min using AUC.
3-hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Food Specialties

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

August 28, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-PEP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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