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

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ClinicalTrials.gov Identifier: NCT02060864
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden

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.

Condition or disease Intervention/treatment Phase
Non-coeliac Gluten Sensitivity Dietary Supplement: AN-PEP Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
Study Start Date : April 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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 Name: 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 Name: Aspergillus Niger-Prolyl Endopeptidase




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060864


Locations
Sweden
Örebro University
Örebro, Sweden, 701 82
Sponsors and Collaborators
DSM Food Specialties

Responsible Party: Robert Brummer, Prof, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02060864     History of Changes
Other Study ID Numbers: AN-PEP-03
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Robert Brummer, Örebro University, Sweden:
enzyme
gluten
food intolerance