Clinical trial NCT02765256: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Official title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Crohn's and Colitis Foundation
First posted: 2016-05-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \[male: \<1.27 mg/dL; female: \<1.03 mg/dL\])
* 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

Primary outcomes:
measure: Change in Disease Activity by Harvey Bradshaw Index
timeFrame: enrollment visit (baseline) and 15 days
measure: Change in Disease Activity by Fecal Calprotectin (FCP)
timeFrame: enrollment visit (baseline) and 15 days
Secondary outcomes:
measure: The Change in High-sensitivity C-reactive Protein (hsCRP)
timeFrame: enrollment visit (baseline) and 15 days
measure: Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).
timeFrame: 105 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Lindsey Albenberg, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: James D Lewis, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: