Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01534312
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2012-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-20', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal calprotectin reduction', 'timeFrame': '4 weeks', 'description': 'Relative reduction in fecal calprotectin measured before and after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical activity index', 'timeFrame': '4 weeks', 'description': 'Simple Clinical Colitis Index, range 0-20'}, {'measure': 'Quality of life', 'timeFrame': '4 weeks', 'description': 'Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)'}, {'measure': 'Endoscopic Mayo score', 'timeFrame': '4 weeks', 'description': 'Grade of inflammation (range 0-3) in rectum according to Mayo score, visually judged during endoscopy'}, {'measure': 'Serial fecal calprotectin', 'timeFrame': '8 weeks', 'description': 'fecal calprotectin week 0-4-6-8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glycopeptides', 'Dietary proteins'], 'conditions': ['Colitis, Ulcerative', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.', 'detailedDescription': 'GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or more\n* Diagnosed ulcerative colitis\n* Signs of clinical activity with SCCAI of 3 or more\n* Extension more than 10 cm and no more than 40 cm from anus\n\nExclusion Criteria:\n\n* Rectal temperature more than 38 degrees Celcius\n* Diagnosed celiac disease or lactose intolerance\n* Unable to speak or understand Danish\n* Prior biologics or systemic steroids 4 weeks up to inclusion'}, 'identificationModule': {'nctId': 'NCT01534312', 'briefTitle': 'Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)', 'orgStudyIdInfo': {'id': 'CGMP in UC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGMP protein', 'description': 'Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose', 'interventionNames': ['Drug: CGMP protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard oral 5ASA maximal dose', 'description': 'Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)', 'interventionNames': ['Drug: Maximal oral 5ASA']}], 'interventions': [{'name': 'CGMP protein', 'type': 'DRUG', 'otherNames': ['Casein glycomacropeptide'], 'description': 'Casein glycomacropeptide purified powder dissolved in 300 ML water once daily', 'armGroupLabels': ['CGMP protein']}, {'name': 'Maximal oral 5ASA', 'type': 'DRUG', 'otherNames': ['Asacol', 'Mezavant', 'Mesalazine'], 'description': '4800 grams/day of Mesalazine (Asacol/Mezavant)', 'armGroupLabels': ['Standard oral 5ASA maximal dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'state': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of medicine V (Hepatology and Gastroenterology)', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Hendrik Vilstrup, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor, University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arla Foods', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}