Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02318134
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fecal Microbiota Transplantation for Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '2495802456@qq.com', 'phone': '15279196058', 'title': 'Dr. Ling Ding', 'organization': 'First Affiliated Hospital of Nanchang University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'deathsNumAffected': 3, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'deathsNumAffected': 4, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'infected ascites', 'notes': 'bacteria or fungi detected in aspirate of intraperitoneal fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteraemia', 'notes': 'positive blood culture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'notes': 'Positive sputum or endotracheal culture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'Positive urine culture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infected pancreatic necrosis', 'notes': 'Positive culture of peripancreatic fluid or pancreatic necrosis obtained by either fine-needle aspiration or during the first percutaneous or endoscopic drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent respiratory failure', 'notes': 'PaO2/FiO2 below 300', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent renal failure', 'notes': 'Serum Creatinine over 170 μmol/l or 1.9 mg/dl', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent circulatory failure', 'notes': 'Systolic blood pressure below 90 mm Hg, not fluid responsive or pH below 7.3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'intra-abdominal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Gastrointestinal Failure Score Equal 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one week after intervention', 'description': 'The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition\\> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infectious Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'title': 'Any infectious complications', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Documented IPN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Suspected or documented IPN', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'infected ascites', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'bacteremia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'pneumonia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days', 'description': 'The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Organ Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'title': 'Any persistent organ failure', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Persistent respiratory failure', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Persistent renal failure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Persistent circulatory failure', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days', 'description': 'The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Interventions or Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'title': 'Percutaneous or endoscopic transmural drainage', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Percutaneous or endoscopic transmural necrosectomy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Open surgery', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mechanical ventilation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Renal replacement therapy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days', 'description': 'number of patients who need extra interventions or surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Intensive Care Time and Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'title': 'Intensive care stay', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '103'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '43'}]}]}, {'title': 'Hospital stay', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '122'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "patients' Length of Intensive care time and hospital stay due to the disease", 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days', 'description': 'patients who die due to the diseases', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diamine Oxidase（DAO）', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-46.2', 'upperLimit': '0.57'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-4.32', 'upperLimit': '0.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'one week after intervention', 'description': 'Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\\*100)', 'unitOfMeasure': 'percent change of DAO', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'D-lactate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.\n\nnormal saline: Normal saline via a nasoduodenal tube.'}, {'id': 'OG001', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.\n\nFecal Microbiota Transplantation: FMT via a nasoduodenal tube with fresh bacteria from healthy donor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '-1.06', 'upperLimit': '0.85'}, {'value': '-0.28', 'groupId': 'OG001', 'lowerLimit': '-3.72', 'upperLimit': '0.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'one week after intervention', 'description': 'Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\\*100).', 'unitOfMeasure': 'percent change of D-lactate', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited between November 2017 and April 2019 from the intensive unit care, Department of Gastroenterology, First Affiliated Hospital of Nanchang University.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FMT Group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', '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': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '25.6', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Causes of pancreatitis', 'classes': [{'categories': [{'title': 'Biliary', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Alcohol', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Hypertriglyceridemia', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drinker', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iintra-abdominal pressure', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '14.5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '14.1', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from first symptoms to admission', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from admission to intervention', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '1.5', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-15', 'size': 362220, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-12T05:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2014-12-12', 'resultsFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-19', 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Gastrointestinal Failure Score Equal 0', 'timeFrame': 'one week after intervention', 'description': 'The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition\\> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Infectious Complications', 'timeFrame': '120 days', 'description': 'The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.'}, {'measure': 'Number of Participants With Organ Failure', 'timeFrame': '120 days', 'description': 'The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.'}, {'measure': 'Number of Participants With Interventions or Surgery', 'timeFrame': '120 days', 'description': 'number of patients who need extra interventions or surgery'}, {'measure': 'Length of Intensive Care Time and Hospital Stay', 'timeFrame': '6 months', 'description': "patients' Length of Intensive care time and hospital stay due to the disease"}, {'measure': 'Mortality', 'timeFrame': '120 days', 'description': 'patients who die due to the diseases'}, {'measure': 'Diamine Oxidase（DAO）', 'timeFrame': 'one week after intervention', 'description': 'Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\\*100)'}, {'measure': 'D-lactate', 'timeFrame': 'one week after intervention', 'description': 'Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\\*100).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe acute pancreatitis', 'Fecal Microbiota Transplantation', 'Intestinal barrier dysfunction', 'Intestinal flora'], 'conditions': ['Acute Pancreatitis', 'Intestinal Bacteria Flora Disturbance', 'Intestinal Dysfunction', 'Fecal Microbiota Transplantation']}, 'referencesModule': {'references': [{'pmid': '18376312', 'type': 'BACKGROUND', 'citation': 'Liu H, Li W, Wang X, Li J, Yu W. Early gut mucosal dysfunction in patients with acute pancreatitis. Pancreas. 2008 Mar;36(2):192-6. doi: 10.1097/MPA.0b013e31815a399f.'}, {'pmid': '23100216', 'type': 'BACKGROUND', 'citation': 'Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.'}, {'pmid': '22310869', 'type': 'BACKGROUND', 'citation': 'Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.'}, {'pmid': '21682755', 'type': 'BACKGROUND', 'citation': 'Landy J, Al-Hassi HO, McLaughlin SD, Walker AW, Ciclitira PJ, Nicholls RJ, Clark SK, Hart AL. Review article: faecal transplantation therapy for gastrointestinal disease. Aliment Pharmacol Ther. 2011 Aug;34(4):409-15. doi: 10.1111/j.1365-2036.2011.04737.x. Epub 2011 Jun 20.'}, {'pmid': '24018052', 'type': 'BACKGROUND', 'citation': 'Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.'}, {'pmid': '23642791', 'type': 'BACKGROUND', 'citation': 'Brandt LJ, Aroniadis OC. An overview of fecal microbiota transplantation: techniques, indications, and outcomes. Gastrointest Endosc. 2013 Aug;78(2):240-9. doi: 10.1016/j.gie.2013.03.1329. Epub 2013 May 2. No abstract available.'}, {'pmid': '24939885', 'type': 'BACKGROUND', 'citation': 'Seekatz AM, Aas J, Gessert CE, Rubin TA, Saman DM, Bakken JS, Young VB. Recovery of the gut microbiome following fecal microbiota transplantation. mBio. 2014 Jun 17;5(3):e00893-14. doi: 10.1128/mBio.00893-14.'}, {'pmid': '25274035', 'type': 'BACKGROUND', 'citation': 'Singh R, Nieuwdorp M, ten Berge IJ, Bemelman FJ, Geerlings SE. The potential beneficial role of faecal microbiota transplantation in diseases other than Clostridium difficile infection. Clin Microbiol Infect. 2014 Nov;20(11):1119-25. doi: 10.1111/1469-0691.12799. Epub 2014 Nov 7.'}, {'pmid': '24707129', 'type': 'BACKGROUND', 'citation': 'Allegretti JR, Hamilton MJ. Restoring the gut microbiome for the treatment of inflammatory bowel diseases. World J Gastroenterol. 2014 Apr 7;20(13):3468-74. doi: 10.3748/wjg.v20.i13.3468.'}, {'pmid': '24855561', 'type': 'BACKGROUND', 'citation': 'Shankar V, Hamilton MJ, Khoruts A, Kilburn A, Unno T, Paliy O, Sadowsky MJ. Species and genus level resolution analysis of gut microbiota in Clostridium difficile patients following fecal microbiota transplantation. Microbiome. 2014 Apr 21;2:13. doi: 10.1186/2049-2618-2-13. eCollection 2014.'}, {'pmid': '23660099', 'type': 'BACKGROUND', 'citation': 'Cui LH, Wang XH, Peng LH, Yu L, Yang YS. [The effects of early enteral nutrition with addition of probiotics on the prognosis of patients suffering from severe acute pancreatitis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2013 Apr;25(4):224-8. doi: 10.3760/cma.j.issn.2095-4352.2013.04.011. Chinese.'}, {'pmid': '35083238', 'type': 'DERIVED', 'citation': 'Ding L, He C, Li X, Huang X, Lei Y, Ke H, Chen H, Yang Q, Cai Y, Liao Y, He W, Xia L, Xiong H, Lu N, Zhu Y. Efficacy and Safety of Faecal Microbiota Transplantation for Acute Pancreatitis: A Randomised, Controlled Study. Front Med (Lausanne). 2022 Jan 10;8:772454. doi: 10.3389/fmed.2021.772454. eCollection 2021.'}], 'seeAlsoLinks': [{'url': 'http://www.cdyfy.com/', 'label': 'the First Affiliated Hospital of Nanchang University'}]}, 'descriptionModule': {'briefSummary': 'The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.', 'detailedDescription': 'Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus\n2. Onset of pancreatitis within \\<=2 weeks\n3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.\n\nExclusion Criteria:\n\n1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula\n2. Pregnancy and lactation women\n3. Not signed the informed consent\n4. Diabetes and autoimmune diseases\n5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.'}, 'identificationModule': {'nctId': 'NCT02318134', 'acronym': 'FMTP', 'briefTitle': 'Fecal Microbiota Transplantation for Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction', 'orgStudyIdInfo': {'id': 'Nanchanguniversity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMT group', 'description': 'In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.', 'interventionNames': ['Procedure: Fecal Microbiota Transplantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Fecal Microbiota Transplantation', 'type': 'PROCEDURE', 'otherNames': ['Fecal Microbiota Therapy', 'Fecal Transplantation'], 'description': 'FMT via a nasoduodenal tube with fresh bacteria from healthy donor', 'armGroupLabels': ['FMT group']}, {'name': 'normal saline', 'type': 'DRUG', 'otherNames': ['normal saline 0.9%'], 'description': 'Normal saline via a nasoduodenal tube.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'the First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'overallOfficials': [{'name': 'Nonghua Lv, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'the Frist Affiliated Hospital of Nanchang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-in-charge', 'investigatorFullName': 'Lingyu Luo', 'investigatorAffiliation': 'The First Affiliated Hospital of Nanchang University'}}}}