Non-coeliac Gluten Sensitivity Clinical Trial
— AN-PEP-03Official title:
Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
| Verified date | August 2015 |
| Source | DSM Food Specialties |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 69 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Örebro University | Örebro |
| Lead Sponsor | Collaborator |
|---|---|
| DSM Food Specialties |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) | 3-hour | No |
| Secondary | 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) | 3-hour | No |
| Secondary | 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) | 3-hour | No |
| Secondary | 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. | 3-hour | No |
| Secondary | 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. | 3-hour | No |
| Secondary | 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. | 3-hour | No |
| Secondary | 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. | 3-hour | No |