Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:01 PM
Study NCT ID:
NCT03865706
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2019-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inulin for Infections in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007444', 'term': 'Inulin'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'def2004@cumc.columbia.edu', 'phone': '857-998-9370', 'title': 'Daniel E. Freedberg, MD, MS', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 90', 'description': 'Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 15, 'seriousNumAtRisk': 30, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 15, 'seriousNumAtRisk': 30, 'deathsNumAffected': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Culture Proven Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Within-individual Change in SCFA Producer Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '7.4'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-8.9', 'upperLimit': '3.7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '-12', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 3', 'description': 'Relative abundance (i.e., proportion) of SCFA producing bacteria within each treatment group, will be assessed via 16S sequencing of rectal swabs. Modified intent-to-treat, comparing baseline vs Day 3 levels of SCFAs among those who receive one or more doses of the intervention and complete both assessments.', 'unitOfMeasure': 'percentage of SCFA producers', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Last Sample Collected, Up to Day 30', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 and at last sample collected, up to Day 30', 'description': 'Proportion of patients who are MDRO-GNB colonized within each treatment group, with MDRO-GNB colonization status classified categorically based on the presence or absence of methicillin-resistant Staphylococcus aureus (MRSA) or Gram negative bacteria (GNB) with third-generation cephalosporins non-susceptibility', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fecal Short Chain Fatty Acid (SCFA) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.18'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.66'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0.46'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.06'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.63'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0.19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 3 and 7', 'description': 'The SCFAs butyrate, acetate, and propionate will be measured from whole stools on a 6490 triple quadrupole mass spectrometer and compared between intervention groups using the first stool sample produced after the Day 3 assessment. Patients who fail to produce a stool from Day 3 to 7 will be excluded from this analysis.', 'unitOfMeasure': 'mMol', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ICU Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '20'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through ICU Day 30', 'description': 'compared between groups, after adjusting for death as a competing risk', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Multidrug Resistant (MDR) Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through 30 days', 'description': 'proportion of patients with culture-proven infections within each treatment group, with culture-proven infections defined as those that have (1) an organism meeting MDRO criteria from a clinical culture, (2) signs and symptoms of infection by Centers for Disease Control (CDC)/National Health and Safety Network (NHSN) guideline definitions, and (3) receive appropriate antibiotics from the treating team', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'Death data will be extracted from the hospital electronic medical record (EMR) which immediately captures in-hospital death and receives monthly mortality updates from the National social security death index.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vancomycin-resistant Enterococcus (VRE) Colonization Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'OG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Last Sample Collected, Up to Day 30', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 and at last sample collected, up to Day 30', 'description': 'Proportion of patients who are VRE colonized within each treatment group, with VRE colonization status classified categorically based on the presence or absence of vancomycin-resistant Enterococcus (VRE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'FG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'FG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.\n\nPlacebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'BG001', 'title': 'Inulin 16 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'BG002', 'title': 'Inulin 32 g/Day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.\n\nInulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube\n\nBroad-spectrum antibiotics: Standard of care treatment for infections'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '71'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '69'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '76'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-24', 'size': 598103, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-21T16:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blind, randomized'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo-controlled trial with 1:1:1 enrollment into three arms: inulin 32 g/day, inulin 16 g/day, and placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2019-03-04', 'resultsFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-21', 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal Short Chain Fatty Acid (SCFA) Levels', 'timeFrame': 'Days 3 and 7', 'description': 'The SCFAs butyrate, acetate, and propionate will be measured from whole stools on a 6490 triple quadrupole mass spectrometer and compared between intervention groups using the first stool sample produced after the Day 3 assessment. Patients who fail to produce a stool from Day 3 to 7 will be excluded from this analysis.'}, {'measure': 'ICU Length of Stay (LOS)', 'timeFrame': 'through ICU Day 30', 'description': 'compared between groups, after adjusting for death as a competing risk'}, {'measure': 'Multidrug Resistant (MDR) Infections', 'timeFrame': 'through 30 days', 'description': 'proportion of patients with culture-proven infections within each treatment group, with culture-proven infections defined as those that have (1) an organism meeting MDRO criteria from a clinical culture, (2) signs and symptoms of infection by Centers for Disease Control (CDC)/National Health and Safety Network (NHSN) guideline definitions, and (3) receive appropriate antibiotics from the treating team'}, {'measure': 'Mortality', 'timeFrame': 'Day 90', 'description': 'Death data will be extracted from the hospital electronic medical record (EMR) which immediately captures in-hospital death and receives monthly mortality updates from the National social security death index.'}], 'primaryOutcomes': [{'measure': 'Within-individual Change in SCFA Producer Level', 'timeFrame': 'Baseline and Day 3', 'description': 'Relative abundance (i.e., proportion) of SCFA producing bacteria within each treatment group, will be assessed via 16S sequencing of rectal swabs. Modified intent-to-treat, comparing baseline vs Day 3 levels of SCFAs among those who receive one or more doses of the intervention and complete both assessments.'}], 'secondaryOutcomes': [{'measure': 'Multidrug Resistant Organism (MDRO)-Gram Negative Bacteria (GNB) Colonization Status', 'timeFrame': 'Day 0 and at last sample collected, up to Day 30', 'description': 'Proportion of patients who are MDRO-GNB colonized within each treatment group, with MDRO-GNB colonization status classified categorically based on the presence or absence of methicillin-resistant Staphylococcus aureus (MRSA) or Gram negative bacteria (GNB) with third-generation cephalosporins non-susceptibility'}, {'measure': 'Vancomycin-resistant Enterococcus (VRE) Colonization Status', 'timeFrame': 'Day 0 and at last sample collected, up to Day 30', 'description': 'Proportion of patients who are VRE colonized within each treatment group, with VRE colonization status classified categorically based on the presence or absence of vancomycin-resistant Enterococcus (VRE)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Antibiotic resistance', 'Intensive care unit', 'Sepsis', 'Nutrition', 'Pathogen colonization'], 'conditions': ['Antibiotic Resistant Infection', 'Nosocomial Infection', 'Pathogen Transmission', 'Nutrition Disorders', 'Critical Illness', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '40237647', 'type': 'DERIVED', 'citation': 'Park H, Abrams JA, Uhlemann AC, Freedberg DE. Gut Colonization With Vancomycin-Resistant Enterococcus Shapes the Gut Microbiome in the Intensive Care Unit. J Infect Dis. 2025 Sep 15;232(3):669-678. doi: 10.1093/infdis/jiaf194.'}, {'pmid': '39806400', 'type': 'DERIVED', 'citation': 'Park H, Lynch E, Tillman A, Lewis K, Jin Z, Uhlemann AC, Abrams JA, Freedberg DE. A phase 2 randomized, placebo-controlled trial of inulin for the prevention of gut pathogen colonization and infection among patients admitted to the intensive care unit for sepsis. Crit Care. 2025 Jan 13;29(1):21. doi: 10.1186/s13054-024-05232-3.'}]}, 'descriptionModule': {'briefSummary': "Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the microbiome is lost and there are no current treatments to restore it. Preliminary data indicates that the prebiotic fiber inulin is safe and may alter the gastrointestinal microbiome to improve gut barrier function, decrease colonization with MDROs, and reduce downstream risk for intensive care unit (ICU)-acquired MDR infections. However, the impact of inulin during critical illness is unknown. This double-blind, randomized clinical trial will test inulin for the prevention of antibiotic resistant infections in the ICU.\n\nThe trial's specific aims are to determine (1) the feasibility, tolerability, and safety of inulin in the intensive care unit; (2) the impact of inulin on gut colonization with antibiotic-resistant pathogens; and (2A/exploratory) the impact of inulin on ICU-acquired antibiotic-resistant infections.", 'detailedDescription': 'The proposed trial hypothesizes that inulin maintains short-chain fatty acid (SCFA)-producing colonic anaerobes and that these bacteria are protective against multi-drug resistant organism (MDRO) colonization and subsequent MDR infection. Inulin, a vegetable-derived non-digestible polysaccharide is well established as the key nutrient source for SCFA-producing bacteria. Previous human studies have shown that (1) inulin increases levels of SCFA producers and SCFAs and (2) that this increase correlates with improved colonic mucosal integrity and resistance to MDR pathogens. In animal studies, inulin improves survival after pathogen challenge or injection with lipopolysaccharide. The overall aim of this clinical trial is to determine whether inulin improves gut colonization resistance against antibiotic-resistant pathogens and therefore prevents antibiotic-resistant infections in the setting of critical illness. To accomplish this, 90 critically ill adults who are receiving broad-spectrum antibiotics will be blindly randomized 1:1:1 to receive placebo, inulin 8 g twice daily, or inulin 16 g twice daily for a minimum of 7 days, with bedside follow-up extending to 30 days or hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized in an eligible medical ICU\n2. Age ≥ 18 years old at the time of hospitalization\n3. With sepsis as defined by the Sepsis-3 (2016) consensus as a known or suspected infection with a sequential organ failure assessment (SOFA) score of ≥2 points above baseline\n4. Received broad-spectrum antibiotics within the last 24 hours or ordered and pending administration\n5. Able to complete enrollment within 4 hours of ICU admission for administration of the intervention within 6 hours of ICU admission\n\nExclusion Criteria:\n\n1. Inability to receive oral or enteric fluids\n2. Inulin allergy\n3. Hyponatremia (serum sodium ≤128 mEq/L)\n4. Immunosuppression, defined as history of solid organ transplant or as receipt of ablative chemotherapy, steroids at the equivalent of ≥5 mg/day prednisone, antimetabolites, anti-tumor necrosis factor (TNF) α agents, calcineurin inhibitors, or mycophenolate\n5. Surgery involving the intestinal lumen within 30 days or known intestinal strictures\n6. Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status, or "no escalation of care" orders\n7. Lack capacity for consent and no appropriate Legally Authorized Representative (LAR)'}, 'identificationModule': {'nctId': 'NCT03865706', 'briefTitle': 'Inulin for Infections in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Prebiotic Inulin to Limit Antimicrobial-Resistant Infections During Critical Illness: A Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'AAAS2576'}, 'secondaryIdInfos': [{'id': 'PR181960', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inulin 32 g/day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days.', 'interventionNames': ['Drug: Inulin Oral Suspension', 'Drug: Broad-spectrum antibiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Inulin 16 g/day', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days.', 'interventionNames': ['Drug: Inulin Oral Suspension', 'Drug: Broad-spectrum antibiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days.', 'interventionNames': ['Drug: Placebo Oral Suspension', 'Drug: Broad-spectrum antibiotics']}], 'interventions': [{'name': 'Inulin Oral Suspension', 'type': 'DRUG', 'otherNames': ['Inulin'], 'description': 'Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube', 'armGroupLabels': ['Inulin 16 g/day', 'Inulin 32 g/day']}, {'name': 'Placebo Oral Suspension', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor', 'armGroupLabels': ['Placebo']}, {'name': 'Broad-spectrum antibiotics', 'type': 'DRUG', 'otherNames': ['Antibiotics'], 'description': 'Standard of care treatment for infections', 'armGroupLabels': ['Inulin 16 g/day', 'Inulin 32 g/day', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniel E Freedberg, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine and Epidemiology', 'investigatorFullName': 'Daniel Freedberg, MD', 'investigatorAffiliation': 'Columbia University'}}}}