Physicians of the Zane Cohen Centre

Crohn's and Colitis Canada Inflammatory Bowel Disease GEM Project

For more information: www.gemproject.ca
Contact: National Project Office
Toll Free: 1-866-803-9632
Email: info@gemproject.ca

Primary Investigators:
Dr. Kenneth Croitoru (National Project Director)
Dr. Hillary Steinhart (Site Investigator)
Dr. Mark Silverberg (Sub-Site Investigator)

Funding provided by:

http://www.crohnsandcolitis.ca/

Objective: To identify why some individuals develop Crohn's disease while others do not. This is accomplished by following healthy individuals who are considered to be at higher risk for developing Crohn's disease over several years and assessing several factors before and after a diagnosis of Crohn's disease is made.

Expectation: This research will allow for an improved and more comprehensive understanding of how human genetics, environmental factors and microbial changes interact and contribute to the development of Crohn's disease.

Eligibility: Anyone who has been diagnosed with Crohn’s disease with at least one sibling or offspring that is generally healthy and is between 6 and 35 years of age.

Participation: Individuals who have been diagnosed with Crohn’s disease: The Proband

o Enrolment involves a brief visit where details regarding their diagnosis are confirmed
o You must have at least one healthy sibling or offspring between the ages of 6 and 35 at the time
of enrolment
o You will be asked to contact or provide contact information for your healthy sibling(s) and/or
offspring so that they can be approached for enrolment into the study

Individuals who have a sibling and/or offspring diagnosed with Crohn’s disease: The Subject

o You must be between the ages of 6 and 35 at the time of enrolment.
o You must have a sibling or parent diagnosed with Crohn’s disease.
o No previous diagnosis of diabetes, IBD or Celiac Disease
o Enrolment involves approximately two 1 hour visits:

• During the visits, subjects must sign consent to participate in the study, complete environmental, dietary and other questionnaires regarding your medical history
• Four tubes of blood are collected
• A stool sample is collected
• Two urine samples are collected
  o Subjects are contacted every 6 months for at least 6 years to review their health status.
  o If subjects develop Crohn’s disease, the sibling or offspring is asked to answer another
  set of questionnaires and will be asked to provide a repeat of blood, stool and urine samples.

Notes: Healthy siblings and/or offspring who do not develop Crohn’s disease during the study, may be asked to answer the questionnaires and provide another set of blood, stool and urine samples if they are chosen to be a healthy control. This control group is used as a comparison group to help determine why some people develop Crohn’s disease while others do not.

Enrolment: Ongoing.

Barriers and Facilitators to medication compliance in IBD patients

Details of Research
Contact: Jhananiee Subendran, Research Student
416-586-4800 ext 2159

Primary Investigator: Erin Kennedy, MD
Enrolment: Complete

Objective: The main aim of this study is to explore the perspectives of individuals with IBD in Toronto, Canada on barriers and facilitators to the compliance of medication.

Expectation: This research may lead to a better understanding of lower compliance rates, and suggest possible ways to improve rates.
Eligibility: Anyone over 18 years diagnosed with IBD (Crohn’s Disease, Ulcerative Colitis or Indeterminate Colitis), have been on any type of treatment for at least 2 years, and are currently on an immunomodulator (Methotrexate) or biologic (Remicade/Humira/etc).

Participation: Participation involves a one-time interview ~30 minutes with the coordinator. Refreshments will be provided.

We would like to thank you in advance for your interest and continued support.

Phase III trial of the Safety and Efficacy of CPP-1X/Sulindac Compared with CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

This is a multicenter study conducted at FAP registries in North America and Europe.  

Objective: To determine if CPP-1X plus Sulindac increases the time to an “FAP disease related event” as compared to CPP-1X alone or Sulindac alone.

These events include 1) disease progression leading to major surgery involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death and/or 3) development of large or pre-cancerous polyps in the rectum/pouch.

Another purpose of the study is to determine the amount of the drugs in  the  blood (pharmacokinetics).  This study will also look to see if there  has been improvement in the disease and if there have been changes to one’s quality of life.   Finally, the study will look at the presence of compounds called polyamines in the diet, from a small piece of bowel  tissue and urine to see if they are a marker for response to treatment.

CPP-1X ( eflornithine HCI) and Sulindac are tablets that in previous clinical trials have shown promise in reducing the risk of developing adenomas in non FAP patients who have polyps removed during colonoscopy.

More information can be obtained by visiting: link

Evolution of the Microbiome in a Pelvic Pouch Model: A Prospective Study to Understand Mechanisms of Ileal Inflammation

Details of Research

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399
Joanne.Stempak@SinaiHealth.ca

Primary Investigator: Mark Silverberg, MD
Enrolment: Ongoing 

Sponsor: Crohn’s and Colitis Canada

Objective: To examine the evolution of the microbiome in the pouch, and its association with pouch inflammation. Patients with Familial Adenomatous Polyposis (FAP) will serve as a control population. This will provide insight on how microbial and genetic factors may be causative in the intestinal inflammation of patients with IBD.

Eligibility: Any Mount Sinai Hospital (MSH) patient who has a confirmed diagnosis of Ulcerative Colitis or Familial Adenomatous Polyposis and is expected to undergo (or recently underwent) a pelvic pouch surgery with an ileostomy at some point.

You are not eligible for this study if:

• You have been diagnosed with Crohn’s Disease
• You were prescribed to take a long-term antibiotic or immunomodulatory therapy following pouch surgery
• You have previously had “backwash” ileitis

Participation:

Participation involves:  

• Providing us with information regarding your family history and disease specifics
• A small blood sample for research purposes
• Providing us with permission to review your medical information regarding IBD
• Filling in 4-day food diaries and food frequency questionnaires prior to your sample collections
• Allowing us to follow you from pouch creation for up to 24 months after your ileostomy closure with data and samples collected at the time of your checkups with the gastroenterologist or surgeon. 
• Providing tissue biopsies for research purposes during your colonoscopy.

Background information:
For many UC patients with severe inflammation, the surgical treatment which removes the large bowel and creation of the pouch from the end of the small intestine, has been considered a cure for UC. However, some patients develop inflammation within the pouch (“pouchitis”). Pouchitis occurs in the small intestine despite the fact that the previous, surgically cured illness (UC) was an inflammatory process confined exclusively to the large intestine. Symptoms of pouchitis include increased stool frequency and urgency, liquid consistency of stool, abdominal cramps and bleeding. Pouchitis occurs after the ileostomy closure and when the pouch is fully in function. This suggests that microbial factors may play a role in the inflammation. Additionally, pouchitis occurs more often in patients with UC than in patients with FAP, who have had the same procedure.  This suggests that there is also a genetic component to inflammation. 

Pouchitis is, therefore, an ideal model for studying the genetic, environmental, and microbial factors involved in new-onset ileal inflammation in individuals thought to have been rendered free of disease via surgical removal of the colon.

We would like to sincerely thank all of our study participants. This research couldn't be possible without your cooperation.

Please contact Joanne Stempak (phone 416-586-4800 x8399) if you are interested in participating in this study.