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

DSM Nutritional Products

Status: Completed

Conditions: Non-coeliac Gluten Sensitivity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AN-PEP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060864

AN-PEP-03

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 Placebo pills

Treatment:

Dietary Supplement: Placebo

AN-PEP 80.000 PPI

Experimental group

Description:

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

Treatment:

Dietary Supplement: AN-PEP

AN-PEP 160.000 PPI

Experimental group

Description:

2 pills AN-PEP 80.000 PPI

Treatment:

Dietary Supplement: AN-PEP