Phase 2 N=8 Randomized Quadruple-blind Treatment

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

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02765256 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Change in Disease Activity by Harvey Bradshaw Index — -5; -3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fluconazole (Drug); Vancomycin (Drug); Neomycin (Drug); Ciprofloxacin (Drug); Polyethylene Glycol 3350 (Drug); Promethazine (Drug); Fluconazole placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Disease Activity by Harvey Bradshaw Index	-5; -3	—
PRIMARY Change in Disease Activity by Fecal Calprotectin (FCP)	-16.5; -380.5	—
SECONDARY The Change in High-sensitivity C-reactive Protein (hsCRP)	4.1; -2	—
SECONDARY Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).	31; 12	—

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.

Eligibility 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: 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02765256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.