Clinical trial NCT01809275: Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease
Official title: A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Inflammatory Bowel Disease
Keywords: Crohn's Disease
Inflammatory Bowel Disease
CDAI
Lead sponsor: Qu Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.


Eligibility criteria: Inclusion Criteria:

* An adult, age 18 and above
* Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
* Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
* Active Crohn's disease at the time of screening
* Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
* Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Have known or suspected hypersensitivity to any component of the product
* Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
* Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
* Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
* Diagnosed with chronic (i.e., long term) hepatitis B or C infection
* Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc.
* Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control
* Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
* Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer

Primary outcomes:
measure: Safety
timeFrame: 8 weeks
measure: Clinical improvement
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical remission
timeFrame: 8 weeks
measure: Clinical response
timeFrame: 8 weeks
measure: Intestinal inflammation
timeFrame: 8 weeks
measure: Systemic inflammation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Zeidler Ledcor Centre
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
state: Ontario
Study officials:
affiliation: Qu Biologics Inc.
name: M D
role: STUDY_DIRECTOR
affiliation: GI Research Institute
name: M D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sutcliffe S, Kalyan S, Pankovich J, Chen JMH, Gluck R, Thompson D, Bosiljcic M, Bazett M, Fedorak RN, Panaccione R, Axler J, Marshall JK, Mullins DW, Kabakchiev B, McGovern DPB, Jang J, Coldman A, Vandermeirsch G, Bressler B, Gunn H. Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. Front Med (Lausanne). 2019 Jul 19;6:170. doi: 10.3389/fmed.2019.00170. eCollection 2019.