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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-coeliac Gluten Sensitivity

Intervention / Treatment
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* Dietary Supplement: AN-PEP
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>2 Placebo pills | Dietary Supplement: Placebo<br> <br> |
| Experimental: AN-PEP 80.000 PPI<br>1 pill AN-PEP 80.000 PPI and 1 pill Placebo. | Dietary Supplement: AN-PEP<br>* Two pills are consumed in the morning with a breakfast<br>* Other names: Aspergillus Niger-Prolyl Endopeptidase;|
| Experimental: AN-PEP 160.000 PPI<br>2 pills AN-PEP 80.000 PPI | Dietary Supplement: AN-PEP<br>* Two pills are consumed in the morning with a breakfast<br>* Other names: Aspergillus Niger-Prolyl Endopeptidase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3-hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3-hour | 
| 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) | 3-hour | 
| 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) | 3-hour | 
| 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. | 3-hour | 
| 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. | 3-hour | 
| 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. | 3-hour | 
| 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. | 3-hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enzyme, gluten, food intolerance