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History of Changes for Study: NCT02765256
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease (Holiday)
Latest version (submitted February 4, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 3, 2016 None (earliest Version on record)
2 May 6, 2016 Eligibility and Study Status
3 October 17, 2016 Recruitment Status, Study Status and Contacts/Locations
4 July 5, 2017 Study Status
5 October 18, 2017 Study Status and Eligibility
6 November 14, 2018 Contacts/Locations, Eligibility and Study Status
7 February 18, 2019 Recruitment Status, Study Status and Contacts/Locations
8 August 12, 2019 Recruitment Status and Study Status
9 December 1, 2019 Study Status
10 December 2, 2019 Arms and Interventions and Study Status
11 August 20, 2020 Study Design, Study Status, Documents
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Results Submission Events
12 February 4, 2021 Study Status, Outcome Measures, More Information, Reported Adverse Events, Baseline Characteristics and Participant Flow
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Study NCT02765256
Submitted Date:  May 6, 2016 (v2)

Study Identification
Unique Protocol ID: 823635
Brief Title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease (Holiday)
Official Title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Secondary IDs:
Study Status
Record Verification: May 2016
Overall Status: Not yet recruiting
Study Start: June 2016
Primary Completion: June 2017 [Anticipated]
Study Completion:
First Submitted: May 2, 2016
First Submitted that
Met QC Criteria:
May 3, 2016
First Posted: May 6, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 6, 2016
Last Update Posted: May 9, 2016 [Estimate]
Sponsor/Collaborators
Sponsor: University of Pennsylvania
Responsible Party: Principal Investigator
Investigator: Lindsey Albenberg
Official Title: Assistant Professor of Pediatrics
Affiliation: University of Pennsylvania
Collaborators: Children's Hospital of Philadelphia
Crohn's and Colitis Foundation
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Study Description
Brief Summary: 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.
Detailed Description:
Conditions
Conditions: Crohn's Disease
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: Fluconazole
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).
Drug: Fluconazole
400mg orally once daily (Day 1-14)
Other Names:
  • Diflucan
Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Names:
  • Vancocin
Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Names:
  • Neo-Fradin
Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Names:
  • Cipro
Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Names:
  • Miralax
Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Names:
  • Phenergan
Placebo Comparator: Placebo
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. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Names:
  • Vancocin
Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Names:
  • Neo-Fradin
Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Names:
  • Cipro
Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Names:
  • Miralax
Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Names:
  • Phenergan
Outcome Measures
Primary Outcome Measures:
1. Change in Disease Activity by Harvey Bradshaw Index
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 Harvey Bradshaw Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications.

[Time Frame: 15 days]
2. Change in Disease Activity by Fecal Calprotectin (FCP)
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.

[Time Frame: 15 days]
Secondary Outcome Measures:
3. The Change in High-sensitivity C-reactive Protein (hsCRP)
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.

[Time Frame: 15 days]
4. Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).
105 days
Eligibility
Minimum Age: 18 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participant is capable of giving informed consent
  • Males or females 18-64 years of age
  • Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female: <1.03 mg/dL])
  • Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63 U/L), and alkaline phosphatase (<126 U/L)
  • Active CD defined as HBI ≥ 8
  • CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 400 mcg/g (within one month of enrollment)
  • 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, or vedolizumab **These medications must have been administered at standard, therapeutic dosages.

Exclusion Criteria:

  • Known or suspected stricturing disease producing obstructive symptoms
  • Active Clostridium difficile infection
  • Unwillingness to provide informed consent
  • Allergy or intolerance to the medications used in this study
  • History of kidney disease
  • History of liver disease
  • Pregnant or lactating females
  • Baseline QTc interval on EKG > 430 in males or > 450 in females
  • Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Contacts/Locations
Central Contact: Unmesha Roy Paladhi, BS
Telephone: 215-746-7138
Email: uroy@mail.med.upenn.edu
Central Contact Backup: Lisa Nessel, MSS, MLSP
Telephone: 215-573-6003
Email: nessel@mail.med.upenn.edu
Study Officials: Lindsey Albenberg, DO
Principal Investigator
University of Pennsylvania
James D Lewis, MD, MSCE
Principal Investigator
University of Pennsylvania
Locations:
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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