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Completed

NCT Number: NCT02060864

Effect of AN-PEP Enzyme on Gluten Digestion in 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.

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Key information

Conditions

Non-coeliac Gluten Sensitivity Food Intolerance Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, 701 82, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AN-PEP

Dietary Supplement

Two pills are consumed in the morning with a breakfast

Other names: Aspergillus Niger-Prolyl Endopeptidase

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

DSM Food Specialties

Industry

Registry information

Official study title

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

Acronym: AN-PEP-03

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2014
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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