Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT02097394
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005335', 'term': 'Combizym'}, {'id': 'D010194', 'term': 'Pancreatin'}], 'ancestors': [{'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of colon polyps', 'timeFrame': 'one year', 'description': 'The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Combizym', 'Bifidobacteri', 'Colon Polyps']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps', 'detailedDescription': 'Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis\n\nExclusion Criteria:\n\n* have organic or other functional disease\n* pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02097394', 'briefTitle': 'The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps', 'orgStudyIdInfo': {'id': 'RJYYXHNK-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combizym-treated group', 'description': 'The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly.', 'interventionNames': ['Drug: Combizym']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bifidobacteri-treated group', 'description': 'The patients who received polypectomy of colon polyps take Bifidobacteri regularly', 'interventionNames': ['Drug: Bifidobacteri']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combizym + Bifidobacteri-treated group', 'description': 'The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly', 'interventionNames': ['Drug: Combizym + Bifidobacteri']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'The patients who received polypectomy of colon polyps take no drugs'}], 'interventions': [{'name': 'Combizym', 'type': 'DRUG', 'otherNames': ['Oryz-Aspergillus Enzyme And Pancreatin Tablet', '(provided by Nordmark Arzneimittel GmbH & Co. KG)'], 'description': 'Combizym( 1 tablet, po, tid)', 'armGroupLabels': ['Combizym-treated group']}, {'name': 'Bifidobacteri', 'type': 'DRUG', 'otherNames': ['Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules', '(produced by Shanghai XinYi Company)'], 'description': 'Bifidobacteri (2 tablet, po, tid)', 'armGroupLabels': ['Bifidobacteri-treated group']}, {'name': 'Combizym + Bifidobacteri', 'type': 'DRUG', 'otherNames': ['Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet)', '(produced by Nordmark Arzneimittel GmbH & Co. KG)', 'Bifidobacteri(Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules)', '(produced by Shanghai XinYi Company)'], 'description': 'Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)', 'armGroupLabels': ['Combizym + Bifidobacteri-treated group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shengliang Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor,chief physician', 'investigatorFullName': 'Shengliang Chen', 'investigatorAffiliation': 'RenJi Hospital'}}}}