Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 10:13 AM
Study NCT ID:
NCT01335503
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2011-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of AN-PEP Enzyme on Gluten Digestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of AN-PEP with a low or high caloric meal on gluten degradation in the duodenum', 'timeFrame': '0-240 min', 'description': 'Difference in gluten (volume x concentration) x time between AN-PEP and placebo with a low or high caloric meal in the duodenum'}], 'secondaryOutcomes': [{'measure': 'Effect of AN-PEP with a low or high caloric meal on gluten degradation in the stomach', 'timeFrame': '0-240 min', 'description': 'Difference in gluten concentration x time between AN-PEP and placebo with a low or high caloric meal in the stomach'}, {'measure': 'Effect of meal caloric density on gastric emptying', 'timeFrame': '0-240 min', 'description': 'Difference in gastric half emptying time by 13CO2:12CO2 in breath between the high and low caloric meals'}, {'measure': 'Effect of AN-PEP and meal caloric density on gastric and duodenal pH', 'timeFrame': '0-240 min', 'description': 'Change in gastric and duodenal pH over time'}, {'measure': 'Effect of caloric density on AN-PEP-mediated gluten degradation in the duodenum', 'timeFrame': '0-240 min', 'description': 'Difference in gluten (concentration) x time between AN-PEP with a high vs low caloric meal in the duodenum'}, {'measure': 'Effect of caloric density on AN-PEP-mediated gluten degradation in the stomach', 'timeFrame': '0-240 min', 'description': 'Difference in gluten concentration x time between AN-PEP with a high vs low caloric meal in the stomach'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gluten'], 'conditions': ['Gluten Digestion']}, 'referencesModule': {'references': [{'pmid': '26352940', 'type': 'DERIVED', 'citation': 'Bartholome R, Salden B, Vrolijk MF, Troost FJ, Masclee A, Bast A, Haenen GR. Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption. PLoS One. 2015 Sep 9;10(9):e0136618. doi: 10.1371/journal.pone.0136618. eCollection 2015.'}, {'pmid': '26040627', 'type': 'DERIVED', 'citation': 'Salden BN, Monserrat V, Troost FJ, Bruins MJ, Edens L, Bartholome R, Haenen GR, Winkens B, Koning F, Masclee AA. Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers. Aliment Pharmacol Ther. 2015 Aug;42(3):273-85. doi: 10.1111/apt.13266. Epub 2015 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to demonstrate how fast and to what extent AN-PEP can degrade gluten in vivo in the stomach and how much gluten enters the small intestine. A second question is whether the caloric density of a meal can influence the efficacy of AN-PEP breakdown.', 'detailedDescription': 'In this trial, the effect of AN-PEP enzyme on gastrointestinal breakdown of gluten will be investigated in healthy subjects. In addition, it will be assessed if meal calories can affect the efficacy of AN-PEP. Subjects receive intragastrically, either AN-PEP or placebo, with either a high or a low caloric meal in a double-blind, randomized, placebo-controlled, cross-over fashion. Gastrointestinal fluid will be sampled to measure breakdown of gluten.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female\n* Age ≥ 18 years but \\< 45 years\n* Hormonal contraceptive treatment\n* Subject has read and understood the information provided on the study and given written informed consent\n\nExclusion Criteria:\n\n* Any medical condition or laboratory test result that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant\n* pregnancy or lactation\n* women not treated with hormonal contraceptive treatment'}, 'identificationModule': {'nctId': 'NCT01335503', 'briefTitle': 'Effect of AN-PEP Enzyme on Gluten Digestion', 'organization': {'class': 'INDUSTRY', 'fullName': 'DSM Food Specialties'}, 'officialTitle': 'Effect of AN-PEP Enzyme on Gastrointestinal Breakdown of Gluten', 'orgStudyIdInfo': {'id': 'AN-PEP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AN-PEP with low caloric meal', 'interventionNames': ['Dietary Supplement: AN-PEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AN-PEP with high caloric meal', 'interventionNames': ['Dietary Supplement: AN-PEP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with low caloric meal', 'interventionNames': ['Dietary Supplement: AN-PEP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with high caloric meal', 'interventionNames': ['Dietary Supplement: AN-PEP']}], 'interventions': [{'name': 'AN-PEP', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Aspergillus Niger Prolyl EndoProtease enzyme (AN-PEP)'], 'description': 'Endoprotease enzyme (AN-PEP)', 'armGroupLabels': ['AN-PEP with high caloric meal', 'AN-PEP with low caloric meal', 'Placebo with high caloric meal', 'Placebo with low caloric meal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Ad Masclee, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DSM Food Specialties', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}