Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-03 @ 6:54 PM
Study NCT ID:
NCT03015467
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein（CRP）', 'timeFrame': '2-4 weeks'}, {'measure': 'Diamine oxidase（DAO）', 'timeFrame': '2-4 weeks'}, {'measure': 'Interleukin', 'timeFrame': '2-4 weeks'}, {'measure': 'tumor necrosis factor-a(TNF-a)', 'timeFrame': '2-4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute pancreatitis', 'intestinal mucosal barrier', 'Fecal Microbiota Transplantation'], 'conditions': ['Acute Pancreatitis', 'Intestinal Bacteria Flora Disturbance', 'Intestinal Dysfunction', 'Fecal Microbiota Transplantation']}, 'referencesModule': {'references': [{'pmid': '21206096', 'type': 'BACKGROUND', 'citation': 'Noor MT, Radhakrishna Y, Kochhar R, Ray P, Wig JD, Sinha SK, Singh K. Bacteriology of infection in severe acute pancreatitis. JOP. 2011 Jan 5;12(1):19-25.'}, {'pmid': '25234043', 'type': 'BACKGROUND', 'citation': 'Murphy SF, Rhee L, Grimm WA, Weber CR, Messer JS, Lodolce JP, Chang JE, Bartulis SJ, Nero T, Kukla RA, MacDougall G, Binghay C, Kolodziej LE, Boone DL. Intestinal epithelial expression of TNFAIP3 results in microbial invasion of the inner mucus layer and induces colitis in IL-10-deficient mice. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 1;307(9):G871-82. doi: 10.1152/ajpgi.00020.2014. Epub 2014 Sep 18.'}, {'pmid': '25334028', 'type': 'BACKGROUND', 'citation': 'Wu LM, Sankaran SJ, Plank LD, Windsor JA, Petrov MS. Meta-analysis of gut barrier dysfunction in patients with acute pancreatitis. Br J Surg. 2014 Dec;101(13):1644-56. doi: 10.1002/bjs.9665. Epub 2014 Oct 21.'}, {'pmid': '24978882', 'type': 'BACKGROUND', 'citation': 'Fishman JE, Levy G, Alli V, Zheng X, Mole DJ, Deitch EA. The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis. Shock. 2014 Sep;42(3):264-70. doi: 10.1097/SHK.0000000000000209.'}, {'pmid': '25872170', 'type': 'BACKGROUND', 'citation': 'Schwender BJ, Gordon SR, Gardner TB. Risk factors for the development of intra-abdominal fungal infections in acute pancreatitis. Pancreas. 2015 Jul;44(5):805-7. doi: 10.1097/MPA.0000000000000334.'}, {'pmid': '25003605', 'type': 'BACKGROUND', 'citation': 'Hall JC, Crawford HC. The conspiracy of autophagy, stress and inflammation in acute pancreatitis. Curr Opin Gastroenterol. 2014 Sep;30(5):495-9. doi: 10.1097/MOG.0000000000000097.'}, {'pmid': '26730036', 'type': 'BACKGROUND', 'citation': 'Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal A, Kozak O. The Effects of Total Colectomy on Bacterial Translocation in a Model of Acute Pancreatitis. Indian J Surg. 2015 Dec;77(Suppl 2):412-8. doi: 10.1007/s12262-013-0855-y. Epub 2013 Jan 31.'}, {'pmid': '26744983', 'type': 'BACKGROUND', 'citation': 'Bongaerts GP, Severijnen RS. A reassessment of the PROPATRIA study and its implications for probiotic therapy. Nat Biotechnol. 2016 Jan;34(1):55-63. doi: 10.1038/nbt.3436.'}, {'pmid': '21327117', 'type': 'BACKGROUND', 'citation': 'Hansson GC, Johansson ME. The inner of the two Muc2 mucin-dependent mucus layers in colon is devoid of bacteria. Gut Microbes. 2010 Jan;1(1):51-54. doi: 10.4161/gmic.1.1.10470.'}, {'pmid': '18257123', 'type': 'BACKGROUND', 'citation': 'Zhang XP, Zhang J, Song QL, Chen HQ. Mechanism of acute pancreatitis complicated with injury of intestinal mucosa barrier. J Zhejiang Univ Sci B. 2007 Dec;8(12):888-95. doi: 10.1631/jzus.2007.B0888.'}]}, 'descriptionModule': {'briefSummary': 'Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis，and the main pathogens from intestinal micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.', 'detailedDescription': 'Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen;\n2. No chronic diseases of the digestive system ;\n3. No chronic diseases of the urinary system;\n4. No chronic metabolic disease;\n5. No chronic disease of immune system\n6. No chronic disease of mental disease\n7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;\n8. No use of addictive drugs and immune inhibitors\n\nExclusion Criteria:\n\n1. not to match the standard of AP\n2. with chronic diseases of the digestive system;\n3. with chronic diseases of the urinary system;\n4. with chronic metabolic disease;\n5. with chronic disease of immune system\n6. with chronic disease of mental disease\n7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women\n8. with use of addictive drugs and immune inhibitors\n9. exceed the age limits'}, 'identificationModule': {'nctId': 'NCT03015467', 'briefTitle': 'Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chengdu Medical College'}, 'officialTitle': 'Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'AM-FMT-SAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treatment for part 1', 'description': 'Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.', 'interventionNames': ['Other: Fecal Microbiota Transplantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for part 2', 'description': 'The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'OTHER', 'otherNames': ['Fecal Microbiota Transplantation (FMT)'], 'description': 'Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1', 'armGroupLabels': ['treatment for part 1']}, {'name': 'normal saline', 'type': 'OTHER', 'otherNames': ['normal saline (NS)'], 'description': 'normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2', 'armGroupLabels': ['Placebo for part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610500', 'city': 'Chendu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-an Li, post doctor', 'role': 'CONTACT', 'email': 'zqzy1983@163.com', 'phone': '+8613680868858'}], 'facility': 'IEC of Chengdu Medical College', 'geoPoint': {'lat': 30.92504, 'lon': 121.03163}}], 'centralContacts': [{'name': 'Li Fang, Ph.D', 'role': 'CONTACT', 'email': 'fangzjt@163.com', 'phone': '+8613458555780'}, {'name': 'Yan Zhou, Ph.D', 'role': 'CONTACT', 'email': '269000947@qq.com', 'phone': '+8618981941992'}], 'overallOfficials': [{'name': 'Li Fang, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chengdu Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chengdu Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}