An interventional study of AN-PEP and Placebo in Non-coeliac Gluten Sensitivity, sponsored by DSM Food Specialties. Completed at 1 site in Sweden. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by DSM Food Specialties · Not applicable, Interventional, and Prevention
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 18 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →DSM Food Specialties is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 Placebo pills
Dietary Supplement: Placebo
1 pill AN-PEP 80.000 PPI and 1 pill Placebo.
Dietary Supplement: AN-PEP
2 pills AN-PEP 80.000 PPI
Dietary Supplement: AN-PEP
Two pills are consumed in the morning with a breakfast
Also known as: Aspergillus Niger-Prolyl Endopeptidase
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)
Time frame: 3-hour
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-hour
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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DSM Food Specialties