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

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.

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