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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 2 Placebo pills |
|
| AN-PEP 80.000 PPI | Experimental | 1 pill AN-PEP 80.000 PPI and 1 pill Placebo. |
|
| AN-PEP 160.000 PPI | Experimental | 2 pills AN-PEP 80.000 PPI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN-PEP | Dietary Supplement | Two pills are consumed in the morning with a breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | 701 82 | Sweden |
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| ID | Term |
|---|---|
| D000073923 | Food Intolerance |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |