Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02472457
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2015-06-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Crohn Disease Exclusion Diet After Single Medication De-escalation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ibdresearch@email.chop.edu', 'phone': '215-590-7801', 'title': 'Ronen Stein, MD', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Adverse event information was obtained via chart review and trial visits', 'eventGroups': [{'id': 'EG000', 'title': 'Free Diet', 'description': 'No dietary restrictions\n\nFree Diet: This diet contains no restrictions.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Crohn Disease Exclusion Diet', 'description': 'The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.\n\nCrohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Relapse-free Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Free Diet', 'description': 'No dietary restrictions\n\nFree Diet: This diet contains no restrictions.'}, {'id': 'OG001', 'title': 'Crohn Disease Exclusion Diet', 'description': 'The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.\n\nCrohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 52 weeks following enrollment', 'description': 'Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant in the free diet group followed the specific carbohydrate diet and was in remission at 52 weeks. 1 participant in the CDED group withdrew prior to 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Time-to-relapse', 'timeFrame': 'Up to 104 weeks', 'description': 'Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)', 'timeFrame': '6 weeks', 'description': 'Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)', 'timeFrame': '52 weeks', 'description': 'Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dietary Compliance', 'timeFrame': 'Up to 52 weeks', 'description': 'Using modified Medication Adherence Rating Scale (MARS) questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Free Diet', 'description': 'No dietary restrictions\n\nFree Diet: This diet contains no restrictions.'}, {'id': 'FG001', 'title': 'Crohn Disease Exclusion Diet', 'description': 'The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.\n\nCrohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 subject followed the Specific Carbohydrate Diet', 'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Free Diet', 'description': 'No dietary restrictions\n\nFree Diet: This diet contains no restrictions.'}, {'id': 'BG001', 'title': 'Crohn Disease Exclusion Diet', 'description': 'The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.\n\nCrohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '16.0', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '16.2', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-10', 'size': 553793, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-08T15:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2015-06-10', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-11', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dietary Compliance', 'timeFrame': 'Up to 52 weeks', 'description': 'Using modified Medication Adherence Rating Scale (MARS) questionnaire'}], 'primaryOutcomes': [{'measure': 'Sustained Relapse-free Remission', 'timeFrame': 'At 52 weeks following enrollment', 'description': 'Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin'}], 'secondaryOutcomes': [{'measure': 'Time-to-relapse', 'timeFrame': 'Up to 104 weeks', 'description': 'Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin'}, {'measure': 'Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)', 'timeFrame': '6 weeks', 'description': 'Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks'}, {'measure': 'Microbial Composition of Gastrointestinal Tract (Types and Quantities of Microorganisms)', 'timeFrame': '52 weeks', 'description': 'Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '24983973', 'type': 'BACKGROUND', 'citation': "Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110."}, {'pmid': '35976282', 'type': 'DERIVED', 'citation': 'Stein R, Daniel SG, Baldassano RN, Feigenbaum K, Kachelries K, Sigall-Boneh R, Weston S, Levine A, Bittinger K. Outcomes and Predictors of Sustained Remission After Drug Withdrawal in Pediatric Crohn Disease. J Pediatr Gastroenterol Nutr. 2022 Nov 1;75(5):608-615. doi: 10.1097/MPG.0000000000003589. Epub 2022 Aug 17.'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to determine whether pediatric Crohn Disease (CD) patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.", 'detailedDescription': "Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition of the gastrointestinal tract with a high risk for complications and need for surgical interventions, particularly in children. Immunomodulators and biologic therapies are effective at inducing and maintaining remission in pediatric CD, yet there is no proven strategy for reducing exposure to medications once sustained remission has been achieved. Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric CD patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of Crohn Disease using the Revised Porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care.\n* Normal Growth Velocity, or Tanner 5\n* Steroid-free Remission (Pediatric Crohn Disease Activity Index Score \\<10 without the height component) for at least 12 months prior to enrollment\n* Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment\n* Stool calprotectin \\<250µg/g during the preceding 3 months\n* Parental/guardian permission (informed consent) and, if appropriate, child assent.\n\nExclusion Criteria:\n\n* Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist.\n* Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.'}, 'identificationModule': {'nctId': 'NCT02472457', 'acronym': 'CEASE', 'briefTitle': 'Crohn Disease Exclusion Diet After Single Medication De-escalation', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Biologic and Immunomodulator Withdrawal in Pediatric Crohn Disease With Deep Clinical Remission Using the Crohn Disease Exclusion Diet', 'orgStudyIdInfo': {'id': '14-011628'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Free Diet', 'description': 'No dietary restrictions', 'interventionNames': ['Other: Free Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crohn Disease Exclusion Diet', 'description': 'The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation.', 'interventionNames': ['Other: Crohn Disease Exclusion Diet']}], 'interventions': [{'name': 'Crohn Disease Exclusion Diet', 'type': 'OTHER', 'description': 'The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.', 'armGroupLabels': ['Crohn Disease Exclusion Diet']}, {'name': 'Free Diet', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'This diet contains no restrictions.', 'armGroupLabels': ['Free Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Ronen Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}