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

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University of Pennsylvania

Status and phase

Completed
Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Neomycin
Drug: Promethazine
Drug: Fluconazole placebo
Drug: Polyethylene Glycol 3350
Drug: Ciprofloxacin
Drug: Fluconazole
Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

8 participants in 2 patient groups, including a placebo group

Fluconazole
Experimental group
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).
Treatment:
Drug: Vancomycin
Drug: Polyethylene Glycol 3350
Drug: Ciprofloxacin
Drug: Fluconazole
Drug: Promethazine
Drug: Neomycin
Placebo
Placebo Comparator group
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).
Treatment:
Drug: Fluconazole placebo
Drug: Vancomycin
Drug: Polyethylene Glycol 3350
Drug: Ciprofloxacin
Drug: Promethazine
Drug: Neomycin

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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