Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT02765256
• Date of registration: 02/05/2016
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease Holiday
• Scientific title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
• Date of first enrolment: August 2016
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02765256
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Lindsey Albenberg, DO
• Affiliation: University of Pennsylvania

• Name: James D Lewis, MD, MSCE
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant is capable of giving informed consent

- Males or females 18-75 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 = 7

- CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350
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,
vedolizumab, or ustekinumab **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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Ciprofloxacin

Drug: Vancomycin

Drug: Polyethylene Glycol 3350

Drug: Fluconazole placebo

Drug: Promethazine

Drug: Fluconazole

Drug: Neomycin

Primary Outcome(s)

Change in Disease Activity by Fecal Calprotectin (FCP) [Time Frame: enrollment visit (baseline) and 15 days]

Change in Disease Activity by Harvey Bradshaw Index [Time Frame: enrollment visit (baseline) and 15 days]

Secondary Outcome(s)

Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). [Time Frame: 105 days]

The Change in High-sensitivity C-reactive Protein (hsCRP) [Time Frame: enrollment visit (baseline) and 15 days]

Secondary ID(s)

823635

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital of Philadelphia

Crohn's and Colitis Foundation

Results

• Results available: Yes
• Date Posted: 08/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02765256