Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT02765256
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D009355', 'term': 'Neomycin'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'C000595212', 'term': 'polyethylene glycol 3350'}, {'id': 'D011398', 'term': 'Promethazine'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'albenbergl@email.chop.edu', 'phone': '267-426-0139', 'title': 'Lindsey Albenberg, DO', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Recruitment was difficult due to intensive methods with large number of/frequent study visits required. Small sample size is a major limitation.'}}, 'adverseEventsModule': {'timeFrame': '105 days', 'eventGroups': [{'id': 'EG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perianal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Defecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Disease Activity by Harvey Bradshaw Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '0'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '-2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease.\n\nGeneral Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points\n\nAbdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points\n\nAbdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points\n\nComplications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Disease Activity by Fecal Calprotectin (FCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.5', 'groupId': 'OG000', 'lowerLimit': '-116.48', 'upperLimit': '94'}, {'value': '-380.5', 'groupId': 'OG001', 'lowerLimit': '-1234', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.', 'unitOfMeasure': 'mcg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Change in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '8.3'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '105 days', 'description': 'Number of Medication Side Effects and/or Adverse Events (AEs)', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole: 400mg orally once daily (Day 1-14)\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nVancomycin: 500mg oral suspension 4 times daily (Day 1-14)\n\nNeomycin: neomycin 1000 mg orally three times daily (Days 1-3)\n\nCiprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14)\n\nPolyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2\n\nPromethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).\n\nFluconazole placebo: Once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '54'}, {'value': '32.5', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '66'}, {'value': '39.5', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-11', 'size': 3784095, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-20T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'dispFirstSubmitDate': '2019-12-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2016-05-02', 'dispFirstSubmitQcDate': '2019-12-01', 'resultsFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2016-05-03', 'dispFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Disease Activity by Harvey Bradshaw Index', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease.\n\nGeneral Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points\n\nAbdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points\n\nAbdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points\n\nComplications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1'}, {'measure': 'Change in Disease Activity by Fecal Calprotectin (FCP)', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.'}], 'secondaryOutcomes': [{'measure': 'The Change in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'enrollment visit (baseline) and 15 days', 'description': 'A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation.'}, {'measure': 'Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).', 'timeFrame': '105 days', 'description': 'Number of Medication Side Effects and/or Adverse Events (AEs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is capable of giving informed consent\n* Males or females 18-75 years of age\n* Normal kidney function (defined by normal serum creatinine \\[male: \\<1.27 mg/dL; female: \\<1.03 mg/dL\\])\n* Normal aspartate aminotransferase \\[AST\\] (\\<41 U/L), alanine aminotransferase \\[ALT\\] (\\<63 U/L), and alkaline phosphatase (\\<126 U/L)\n* Active CD defined as HBI ≥ 7\n* CRP \\> 5 mg/dL or hs-CRP \\> 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) \\> - - 350 mcg/g (within one month of enrollment)\n* Have been treated with one of the following therapies\\*\\* for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response \\[LOR\\] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab \\*\\*These medications must have been administered at standard, therapeutic dosages.\n\nExclusion Criteria:\n\n* Known or suspected stricturing disease producing obstructive symptoms\n* Active Clostridium difficile infection\n* Unwillingness to provide informed consent\n* Allergy or intolerance to the medications used in this study\n* History of kidney disease\n* History of liver disease\n* Pregnant or lactating females\n* Baseline QTc interval on EKG \\> 430 in males or \\> 450 in females\n* Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures'}, 'identificationModule': {'nctId': 'NCT02765256', 'acronym': 'Holiday', 'briefTitle': "Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': "Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease", 'orgStudyIdInfo': {'id': '823635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluconazole', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).', 'interventionNames': ['Drug: Fluconazole', 'Drug: Vancomycin', 'Drug: Neomycin', 'Drug: Ciprofloxacin', 'Drug: Polyethylene Glycol 3350', 'Drug: Promethazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).', 'interventionNames': ['Drug: Vancomycin', 'Drug: Neomycin', 'Drug: Ciprofloxacin', 'Drug: Polyethylene Glycol 3350', 'Drug: Promethazine', 'Drug: Fluconazole placebo']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': '400mg orally once daily (Day 1-14)', 'armGroupLabels': ['Fluconazole']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': '500mg oral suspension 4 times daily (Day 1-14)', 'armGroupLabels': ['Fluconazole', 'Placebo']}, {'name': 'Neomycin', 'type': 'DRUG', 'otherNames': ['Neo-Fradin'], 'description': 'neomycin 1000 mg orally three times daily (Days 1-3)', 'armGroupLabels': ['Fluconazole', 'Placebo']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cipro'], 'description': 'ciprofloxacin 750 mg orally twice daily (Day 4-14)', 'armGroupLabels': ['Fluconazole', 'Placebo']}, {'name': 'Polyethylene Glycol 3350', 'type': 'DRUG', 'otherNames': ['Miralax'], 'description': '238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2', 'armGroupLabels': ['Fluconazole', 'Placebo']}, {'name': 'Promethazine', 'type': 'DRUG', 'otherNames': ['Phenergan'], 'description': 'PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).', 'armGroupLabels': ['Fluconazole', 'Placebo']}, {'name': 'Fluconazole placebo', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Lindsey Albenberg, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'James D Lewis, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': "Crohn's and Colitis Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Lindsey Albenberg', 'investigatorAffiliation': 'University of Pennsylvania'}}}}