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

Primary Purpose

Non-coeliac Gluten Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
AN-PEP
Placebo
Sponsored by
DSM Food Specialties
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-coeliac Gluten Sensitivity focused on measuring enzyme, gluten, food intolerance

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Örebro University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

AN-PEP 80.000 PPI

AN-PEP 160.000 PPI

Arm Description

2 Placebo pills

1 pill AN-PEP 80.000 PPI and 1 pill Placebo.

2 pills AN-PEP 80.000 PPI

Outcomes

Primary Outcome Measures

Effect of 160.000 PPI AN-PEP on duodenal gluten
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)

Secondary Outcome Measures

Effect of 160.000 PPI AN-PEP on gastric gluten
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)
Effect of 80.000 PPI AN-PEP on duodenal gluten
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)
Effect of 80.000 PPI AN-PEP on gastric gluten AUC
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)
Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
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.
Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
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.
Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
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.
Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
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.

Full Information

First Posted
February 11, 2014
Last Updated
August 27, 2015
Sponsor
DSM Food Specialties
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1. Study Identification

Unique Protocol Identification Number
NCT02060864
Brief Title
Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
Acronym
AN-PEP-03
Official Title
Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DSM Food Specialties

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-coeliac Gluten Sensitivity
Keywords
enzyme, gluten, food intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 Placebo pills
Arm Title
AN-PEP 80.000 PPI
Arm Type
Experimental
Arm Description
1 pill AN-PEP 80.000 PPI and 1 pill Placebo.
Arm Title
AN-PEP 160.000 PPI
Arm Type
Experimental
Arm Description
2 pills AN-PEP 80.000 PPI
Intervention Type
Dietary Supplement
Intervention Name(s)
AN-PEP
Other Intervention Name(s)
Aspergillus Niger-Prolyl Endopeptidase
Intervention Description
Two pills are consumed in the morning with a breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect of 160.000 PPI AN-PEP on duodenal gluten
Description
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)
Time Frame
3-hour
Secondary Outcome Measure Information:
Title
Effect of 160.000 PPI AN-PEP on gastric gluten
Description
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)
Time Frame
3-hour
Title
Effect of 80.000 PPI AN-PEP on duodenal gluten
Description
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)
Time Frame
3-hour
Title
Effect of 80.000 PPI AN-PEP on gastric gluten AUC
Description
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)
Time Frame
3-hour
Title
Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
Description
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.
Time Frame
3-hour
Title
Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
Description
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.
Time Frame
3-hour
Title
Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
Description
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.
Time Frame
3-hour
Title
Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
Description
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.
Time Frame
3-hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Örebro University
City
Örebro
ZIP/Postal Code
701 82
Country
Sweden

12. IPD Sharing Statement

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

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