Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05485103
Status:
UNKNOWN
Last Update Posted:
2023-12-26
First Post:
2022-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The quality of bowel preparation evaluated by endoscopists during colonoscopy.', 'timeFrame': 'During colonoscopy examination', 'description': 'The quality of bowel preparation will be evaluated with the Boston bowel preparation scale (BBPS), including the total Boston score (range 0-9, score 8-9 means excellent, 7 means good, less than 7 means bad) and score of per bowel segment (maximum 3).'}, {'measure': 'Number of Participants with increased Disease activity after colonoscopy.', 'timeFrame': 'Within 7 days after colonoscopy', 'description': "Disease activity will be assessed using C-reactive protein (CRP) measurement, the modified Mayo score in ulcerative colitis and the Crohn's Disease Activity Index score in Crohn's Disease. If the result after colonoscopy was higher than before, the participant may be considered with increased disease activity."}], 'secondaryOutcomes': [{'measure': 'Tolerance score of participants after bowel preparation.', 'timeFrame': 'After bowel preparation and before colonoscopy', 'description': 'Tolerance score is defined range 0-10 (0 means totally intolerant, 10 means feel really good).'}, {'measure': 'Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease after colonoscopy.', 'timeFrame': 'Within 30 days after colonoscopy', 'description': 'Number of Participants who has a record of outpatient or emergency treatment due to aggravation of disease within 30 days after colonoscopy.'}, {'measure': 'Number of Participants hospitalized because of aggravation of disease after colonoscopy.', 'timeFrame': 'Within 30 days after colonoscopy', 'description': 'Number of Participants who is hospitalized because of aggravation of disease within 30 days after colonoscopy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['modified bowel preparation method', 'inflammatory bowel disease', 'risk factors', 'quality of bowel preparation'], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '35579796', 'type': 'BACKGROUND', 'citation': 'Sultan K, Trindade AJ. Concise Commentary: Is Splitting the Difference? Identifying Risk Factors Associated with Suboptimal Bowel Preparation for Colonoscopy Among IBD Patients. Dig Dis Sci. 2022 Oct;67(10):4602-4603. doi: 10.1007/s10620-022-07533-5. Epub 2022 May 17. No abstract available.'}, {'pmid': '35689818', 'type': 'BACKGROUND', 'citation': 'Kim KO, Kim EY, Lee YJ, Lee HS, Kim ES, Chung YJ, Jang BI, Kim SK, Yang CH. Efficacy, safety and tolerability of oral sulphate tablet for bowel preparation in patients with inflammatory bowel disease: A multicentre randomized controlled study. J Crohns Colitis. 2022 Nov 23;16(11):1706-1713. doi: 10.1093/ecco-jcc/jjac080.'}, {'pmid': '34487155', 'type': 'BACKGROUND', 'citation': 'Wijnands AM, Te Groen M, Peters Y, Kaptein AA, Oldenburg B, Hoentjen F, Lutgens MWMD. Patients Prioritize a Low-volume Bowel Preparation in Colitis-associated Colorectal Cancer Surveillance: A Discrete Choice Experiment. Inflamm Bowel Dis. 2022 Jul 1;28(7):1053-1060. doi: 10.1093/ibd/izab221.'}, {'pmid': '33661246', 'type': 'BACKGROUND', 'citation': 'Reddy P, Mencin A, Lebwohl B. Risk Factors for Suboptimal Bowel Preparation for Colonoscopy in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2021 Jul 1;73(1):e1-e6. doi: 10.1097/MPG.0000000000003114.'}, {'pmid': '34034275', 'type': 'BACKGROUND', 'citation': 'Neri B, Scarozza P, Giannarelli D, Sena G, Mossa M, Lolli E, Calabrese E, Biancone L, Grasso E, Di Iorio L, Troncone E, Monteleone G, Paoluzi OA, Del Vecchio Blanco G. Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2021 Jul 1;33(7):977-982. doi: 10.1097/MEG.0000000000002167.'}, {'pmid': '33994129', 'type': 'BACKGROUND', 'citation': 'Maida M, Morreale GC, Sferrazza S, Sinagra E, Scalisi G, Vitello A, Vettori G, Rossi F, Catarella D, Di Bartolo CE, Schillaci D, Raimondo D, Camilleri S, Orlando A, Macaluso FS. Effectiveness and safety of 1L PEG-ASC preparation for colonoscopy in patients with inflammatory bowel diseases. Dig Liver Dis. 2021 Sep;53(9):1171-1177. doi: 10.1016/j.dld.2021.04.006. Epub 2021 May 12.'}, {'pmid': '32237946', 'type': 'BACKGROUND', 'citation': 'Negreanu L, Voiosu T, State M, Mateescu RB. Quality of colonoscopy preparation in patients with inflammatory bowel disease: retrospective analysis of 348 colonoscopies. J Int Med Res. 2020 Apr;48(4):300060520903654. doi: 10.1177/0300060520903654.'}, {'pmid': '30339950', 'type': 'BACKGROUND', 'citation': 'Megna B, Weiss J, Ley D, Saha S, Pfau P, Grimes I, Li Z, Caldera F. Clear liquid diet before bowel preparation predicts successful chromoendoscopy in patients with inflammatory bowel disease. Gastrointest Endosc. 2019 Feb;89(2):373-379.e2. doi: 10.1016/j.gie.2018.09.039. Epub 2018 Oct 16.'}, {'pmid': '30785181', 'type': 'BACKGROUND', 'citation': 'Briot C, Faure P, Parmentier AL, Nachury M, Trang C, Viennot S, Altwegg R, Bulois P, Thomassin L, Serrero M, Ah-Soune P, Gilletta C, Plastaras L, Simon M, Dray X, Caillo L, Del Tedesco E, Abitbol V, Zallot C, Degand T, Rossi V, Bonnaud G, Colin D, Morel B, Winkfield B, Danset JB, Filippi J, Amiot A, Attar A, Levy J, Peyrin-Biroulet L, Vuitton L; CLEAN Study Group. Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study. J Crohns Colitis. 2019 Sep 19;13(9):1121-1130. doi: 10.1093/ecco-jcc/jjz040.'}, {'pmid': '30254405', 'type': 'BACKGROUND', 'citation': 'Spiceland CM, Lodhia N. Endoscopy in inflammatory bowel disease: Role in diagnosis, management, and treatment. World J Gastroenterol. 2018 Sep 21;24(35):4014-4020. doi: 10.3748/wjg.v24.i35.4014.'}, {'pmid': '30390208', 'type': 'BACKGROUND', 'citation': 'Martel M, Menard C, Restellini S, Kherad O, Almadi M, Bouchard M, Barkun AN. Which Patient-Related Factors Determine Optimal Bowel Preparation? Curr Treat Options Gastroenterol. 2018 Dec;16(4):406-416. doi: 10.1007/s11938-018-0208-9.'}, {'pmid': '29019424', 'type': 'BACKGROUND', 'citation': 'Bezzio C, Andreozzi P, Casini V, Manes G, Saibeni S. Endoscopy for patients affected by inflammatory bowel disease: bowel preparation and sedation. Expert Rev Gastroenterol Hepatol. 2018 Feb;12(2):119-124. doi: 10.1080/17474124.2017.1390430. Epub 2017 Oct 17.'}, {'pmid': '26866392', 'type': 'BACKGROUND', 'citation': 'Shobar RM, Velineni S, Keshavarzian A, Swanson G, DeMeo MT, Melson JE, Losurdo J, Engen PA, Sun Y, Koenig L, Mutlu EA. The Effects of Bowel Preparation on Microbiota-Related Metrics Differ in Health and in Inflammatory Bowel Disease and for the Mucosal and Luminal Microbiota Compartments. Clin Transl Gastroenterol. 2016 Feb 11;7(2):e143. doi: 10.1038/ctg.2015.54.'}, {'pmid': '24975529', 'type': 'BACKGROUND', 'citation': 'Nett A, Velayos F, McQuaid K. Quality bowel preparation for surveillance colonoscopy in patients with inflammatory bowel disease is a must. Gastrointest Endosc Clin N Am. 2014 Jul;24(3):379-92. doi: 10.1016/j.giec.2014.03.004. Epub 2014 May 6.'}, {'pmid': '23664621', 'type': 'BACKGROUND', 'citation': 'Bessissow T, Van Keerberghen CA, Van Oudenhove L, Ferrante M, Vermeire S, Rutgeerts P, Van Assche G. Anxiety is associated with impaired tolerance of colonoscopy preparation in inflammatory bowel disease and controls. J Crohns Colitis. 2013 Dec;7(11):e580-7. doi: 10.1016/j.crohns.2013.04.011. Epub 2013 May 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of modified colonoscopy bowel preparation method compared with traditional method on bowel cleansing effect, colonoscopy examination effect and clinical condition of inflammatory bowel disease patients. Risk factors affecting the quality of bowel preparation will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis: inflammatory bowel disease (IBD) patients, including ulcerative colitis (UC) and Crohn's disease (CD), have colonic involvement.\n* Patients and/or family members can understand the study protocol and are willing to participate in the study and provide informed consent in writing.\n\nExclusion Criteria:\n\n* The diagnosis is not definite.\n* Toxic megacolon, gastrointestinal perforation or other acute abdominal diseases; Patients with gastrointestinal bleeding with unstable vital signs.\n* Patients after colon surgery.\n* Serious underlying diseases, organ failure, or inability to cooperate with colonoscopy for other reasons.\n* Patients can not cooperate with the use of polyethylene glycol or glycerin enema.\n* Patients or family members cannot understand the conditions and objectives of this study."}, 'identificationModule': {'nctId': 'NCT05485103', 'briefTitle': 'A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Prospective Study of the Effect of Modified Colonoscopy Bowel Preparation Program on Intestinal Cleaning, Examination and Disease in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'ZS-3300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified bowel preparation method group', 'description': 'One day before the colonoscopy, only asol (or other intestinal nutrient solution) was taken. On the examination day (4 hours before), 1 bag of polyethylene glycol solution + (2 hours before) glycerin enema 110ml was taken', 'interventionNames': ['Drug: Polyethylene Glycols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional bowel preparation method group', 'description': 'Low residue diet 2 days before the colonoscopy, take 2 bags of polyethylene glycol solution the night before the examination and 1 bag of which on the examination day (4 hours before)', 'interventionNames': ['Drug: Polyethylene Glycols']}], 'interventions': [{'name': 'Polyethylene Glycols', 'type': 'DRUG', 'otherNames': ['glycerin enema', 'asol'], 'description': 'Take asol as total enteral nutrition, and take polyethylene glycols and glycerin enema as bowel preparations', 'armGroupLabels': ['Modified bowel preparation method group', 'Traditional bowel preparation method group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Xu, MD', 'role': 'CONTACT', 'email': 'xuhui10799@pumch.cn', 'phone': '+86-010-69151591'}, {'name': 'Hui Xu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinjuan Liu', 'role': 'CONTACT'}], 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zuoyan Wu', 'role': 'CONTACT'}], 'facility': 'Beijing Sixth Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Yang', 'role': 'CONTACT'}], 'facility': 'Heilongjiang Provincial Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanjun Chen', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuying Xu', 'role': 'CONTACT'}], 'facility': 'The first Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Baotou', 'state': 'Neimenggu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Liu', 'role': 'CONTACT'}], 'facility': 'The second Affiliated Hospital of Baotou Medical Colledge', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linting Xun', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Yunnan Province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junmei Zhang', 'role': 'CONTACT'}], 'facility': 'Beijing Rectum Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hui Xu, MD', 'role': 'CONTACT', 'email': 'xuhui10799@pumch.cn', 'phone': '+86-010-69151591'}, {'name': 'Hong Yang, MD', 'role': 'CONTACT', 'email': 'yangh@pumch.cn'}], 'overallOfficials': [{'name': 'Hui Xu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}