Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05034458
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2021-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diet in Pediatric Crohn´s Disease Treated With Biologics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-13', 'size': 144943, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-28T17:01', 'hasProtocol': True}, {'date': '2021-05-13', 'size': 121884, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-28T16:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2021-06-12', 'studyFirstSubmitQcDate': '2021-08-28', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with calprotectin less than 250 at week 12', 'timeFrame': 'week 12', 'description': 'Number of participants who achieve normal fecal calprotectin after the diet'}, {'measure': 'Level of calprotectin', 'timeFrame': 'week 12', 'description': 'To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '12 weeks', 'description': 'Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '37610564', 'type': 'DERIVED', 'citation': "Arcucci MS, Menendez L, Orsi M, Gallo J, Guzman L, Busoni V, Lifschitz C. Role of adjuvant Crohn's disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn's disease having biochemical activity: A randomized, pilot study. Indian J Gastroenterol. 2024 Feb;43(1):199-207. doi: 10.1007/s12664-023-01416-x. Epub 2023 Aug 23."}]}, 'descriptionModule': {'briefSummary': 'Cded in remission patients with high calprotectin', 'detailedDescription': 'Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under 18 years of age\n* With a diagnosis of CD\n* Who have completed remission induction with biologic therapy\n* Who are on maintenance biologic therapy\n* Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).\n\nExclusion Criteria:\n\n* Children who are unable to receive enteral dietary intake\n* Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development\n* Children already on special diets'}, 'identificationModule': {'nctId': 'NCT05034458', 'briefTitle': 'Diet in Pediatric Crohn´s Disease Treated With Biologics', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': "Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.", 'orgStudyIdInfo': {'id': '5992'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet', 'description': 'Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin.', 'interventionNames': ["Dietary Supplement: Crohn's disease exclusion diet"]}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients with normal treatment( biologic treatment indicated for CD)'}], 'interventions': [{'name': "Crohn's disease exclusion diet", 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive, in addition to their normal treatment, polymeric formula + diet', 'armGroupLabels': ['Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1199', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Marina Orsi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'MARIA SOLEDAD ARCUCCI', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}