NCT02060864: AN-PEP-03

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

Completed NA Last updated 27 August 2015

What this trial tests

NA trial testing AN-PEP in Non-coeliac Gluten Sensitivity in 18 participants. Completed in 1 August 2015.

Timeline

1 April 2014

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	DSM Food Specialties
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	18
Start date	1 April 2014
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	1 location across Sweden

Drugs / interventions tested

• AN-PEP
• Placebo

Conditions studied

• Non-coeliac Gluten Sensitivity — all drugs for Non-coeliac Gluten Sensitivity →

Sponsor

DSM Food Specialties — full company profile →

Who can join

Adults 18 to 69, any sex, with Non-coeliac Gluten Sensitivity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized clinical trial: Effective gluten degradation by Aspergillus niger-derived enzyme in a complex meal setting.
   König J, Holster S, Bruins MJ, Brummer RJ. · · 2017 · cited 45× · PMID 29026170 · DOI 10.1038/s41598-017-13587-7
2. Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials.
   Gottlieb K, Dawson J, Hussain F, Murray JA. · · 2015 · cited 26× · PMID 25725041 · DOI 10.1093/gastro/gov006
3. Celiac Disease and Non-celiac Wheat Sensitivity: State of Art of Non-dietary Therapies.
   Serena G, D'Avino P, Fasano A. · · 2020 · cited 13× · PMID 33015123 · DOI 10.3389/fnut.2020.00152
4. Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
   Girbal-González M, Pérez-Cano FJ. · · 2025 · cited 2× · PMID 41010485 · DOI 10.3390/nu17182960
5. From an understanding of etiopathogenesis to novel therapies-what is new in the treatment of celiac disease?
   Skoracka K, Hryhorowicz S, Tovoli F, Raiteri A, et al · · 2024 · cited 2× · PMID 38698821 · DOI 10.3389/fphar.2024.1378172