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

NCT02060864 | Completed DMC

• 1 other identifier: AN-PEP-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-coeliac Gluten Sensitivity

Keywords

enzyme; gluten; food intolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Effect of 160.000 PPI AN-PEP on gastric gluten

  3-hour

• Effect of 80.000 PPI AN-PEP on duodenal gluten

  3-hour

• Effect of 80.000 PPI AN-PEP on gastric gluten AUC

  3-hour

• Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction

  3-hour

• Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction

  3-hour

Study Arms (3)

Placebo

PLACEBO COMPARATOR

2 Placebo pills

Dietary Supplement: Placebo

AN-PEP 80.000 PPI

EXPERIMENTAL

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

Dietary Supplement: AN-PEP

AN-PEP 160.000 PPI

EXPERIMENTAL

2 pills AN-PEP 80.000 PPI

Dietary Supplement: AN-PEP

Interventions

AN-PEP DIETARY_SUPPLEMENT

Two pills are consumed in the morning with a breakfast

Also known as: Aspergillus Niger-Prolyl Endopeptidase

AN-PEP 160.000 PPI; AN-PEP 80.000 PPI

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DSM Food Specialties: lead

Study Sites (1)

Örebro University

Örebro, 701 82, Sweden

Location

MeSH Terms

Conditions

Food Intolerance

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 12, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

SE (1)