Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 11:55 PM
Study NCT ID:
NCT03742934
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Peptide Formula for Bowel Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'assessed through study completion, an average of 1 year', 'description': 'Adverse events'}, {'measure': 'Bristol scores', 'timeFrame': 'assessed through study completion, an average of 1 year', 'description': 'average Bristol scores during bowel preparation'}], 'primaryOutcomes': [{'measure': 'Cleansing score', 'timeFrame': 'assessed through study completion, an average of 1 year', 'description': 'Cleansing scores were recorded according to a predetermined criterion'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'assessed through study completion, an average of 1 year', 'description': 'Percentage of positive cases'}, {'measure': 'Completion rate', 'timeFrame': 'assessed through study completion, an average of 1 year', 'description': 'CE was considered complete when the cecum was reached within recording time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bowel preparation'], 'conditions': ['Capsule Endoscopy', 'Pediatric Disorder']}, 'referencesModule': {'references': [{'pmid': '26134966', 'type': 'BACKGROUND', 'citation': 'Goyal J, Goel A, McGwin G, Weber F. Analysis of a grading system to assess the quality of small-bowel preparation for capsule endoscopy: in search of the Holy Grail. Endosc Int Open. 2014 Sep;2(3):E183-6. doi: 10.1055/s-0034-1377521. Epub 2014 Jul 16.'}, {'pmid': '18072052', 'type': 'BACKGROUND', 'citation': 'van Tuyl SA, den Ouden H, Stolk MF, Kuipers EJ. Optimal preparation for video capsule endoscopy: a prospective, randomized, single-blind study. Endoscopy. 2007 Dec;39(12):1037-40. doi: 10.1055/s-2007-966988.'}]}, 'descriptionModule': {'briefSummary': 'Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indications of capsule endoscopy;\n* Informed consent form obtained.\n\nExclusion Criteria:\n\n* Contraindication of capsule endoscopy;\n* Unwilling to participate;\n* Formula allergy;\n* Unable to swallow the capsule.'}, 'identificationModule': {'nctId': 'NCT03742934', 'briefTitle': 'Short Peptide Formula for Bowel Preparation', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy', 'orgStudyIdInfo': {'id': 'PreparationVCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formula group', 'description': 'short peptide formula prior to capsule endoscopy', 'interventionNames': ['Other: Short peptide']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'regular liquid diet', 'interventionNames': ['Other: Liquid diet']}], 'interventions': [{'name': 'Short peptide', 'type': 'OTHER', 'description': 'Short peptide formula during bowel preparation', 'armGroupLabels': ['Formula group']}, {'name': 'Liquid diet', 'type': 'OTHER', 'description': 'Liquid diet during bowel preparation', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's hospital of Fudan university", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ying Huang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "The director of gastroenterology of Children's Hospital of Fudan University", 'investigatorFullName': 'Ying HUANG', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}