Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 11:50 PM
Study NCT ID:
NCT00853034
Status:
COMPLETED
Last Update Posted:
2009-02-27
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-26', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastrointestinal effects', 'prebiotic'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '18978172', 'type': 'BACKGROUND', 'citation': 'Cloetens L, De Preter V, Swennen K, Broekaert WF, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Dose-response effect of arabinoxylooligosaccharides on gastrointestinal motility and on colonic bacterial metabolism in healthy volunteers. J Am Coll Nutr. 2008 Aug;27(4):512-8. doi: 10.1080/07315724.2008.10719733.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS) on the colonic metabolism and microbial composition, and to compare these effects with the reference prebiotic fructo-oligosaccharide enriched inulin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* 18-45 years\n* regular eating pattern\n\nExclusion Criteria:\n\n* gastrointestinal complaints\n* antibiotic intake\n* medication influencing gut transit or microbiota\n* abdominal surgery\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00853034', 'briefTitle': 'Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Effects of Arabinoxylan-Oligosaccharides on Colonic Metabolism and Microbial Composition Compared to Other Prebiotics in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AXOS 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FOS-IN', 'description': 'prebiotic fructo-oligosaccharide enriched inulin', 'interventionNames': ['Dietary Supplement: FOS-IN']}, {'type': 'EXPERIMENTAL', 'label': 'AXOS', 'description': 'arabinoxylan-oligosaccharides (AXOS)', 'interventionNames': ['Dietary Supplement: AXOS']}], 'interventions': [{'name': 'FOS-IN', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Synergy1, Orafti, Tienen'], 'description': 'prebiotic fructo-oligosaccharide enriched inulin\n\nintake period: 2 weeks, 1.25 or 2.50g every morning and evening', 'armGroupLabels': ['FOS-IN']}, {'name': 'AXOS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'arabinoxylan-oligosaccharides (AXOS)\n\nintake period: 2 weeks, 1.25 or 2.50g every morning and evening', 'armGroupLabels': ['AXOS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Gastrointestinal Research, Laboratory Digestion and Absorption', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Kristin Verbeke, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}}}}