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ICARUS-IBD: International study of COVID-19 Antibody Response Under Sustained immune suppression in IBD

Contact: Raquel Milgrom
E-mail:

Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing

Objective: This is a global research effort to follow IBD patients at infusion centers around the world. We will measure the baseline prevalence of SARS-CoV-2, the virus that causes COVID-19, exposure by antibody testing (involves taking a blood sample) and follow with scheduled testing (blood sample at each of the visits) every 8 weeks over a 48-week period. . Through analysis of clinical data and patients’ social behaviors(questionnaire), we will be able to identify social, treatment-related, and biological factors that determine whether patients acquire mild, asymptomatic, or severe disease. This study could lead to improvements in understanding the effects of medications and viral infections in IBD and help on future pandemic preparations and epidemiological studies.

Participation involves:

• You have been diagnosed by your physician with IBD (Crohn’s Disease, Ulcerative Colitis, IBD-U)


• You are 18 years or older


• You are currently receiving treatment for IBD with Infliximab, other biologics or Vedolizumab


• You may or may not been diagnosed with COVID-19

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

Please contact Raquel Milgrom if you are interested in participating in this study.

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The Identification of Genes for Inflammatory Bowel Disease

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing

Sponsor: This initiative is funded by the National Institutes of Health in the United States and has allowed us to form an IBD Genetic Research Centre in order to build upon our previous efforts in this area.

Objective: Objective is to identify new genes and other biomarkers that may be responsible for causing Inflammatory Bowel Disease (IBD) and understand the role of previously identified biomarkers in IBD.
Expectation: This research will lead to a better understanding of why the disease occurs, easier diagnostic tools that may avoid the need for colonoscopies, better therapies or even a cure.
Eligibility: Anyone who has a confirmed diagnosis of IBD (either Crohn's Disease or Ulcerative Colitis). Also, if you do not have IBD (i.e. Crohn's Disease or ulcerative colitis) and do not have a family history of IBD and are willing to provide a blood sample as a healthy control, your help would be greatly appreciated.

Participation:

• Participation is very brief and involves providing us with:
  • Information regarding your family history and disease specifics
  • A small blood sample for genetic testing
  • Permission to review your medical information regarding IBD
• You will not have to see any physicians at Mount Sinai Hospital

Notes:

• Those with a family history of IBD may be asked for permission to contact affected individuals to participate as well.
• Those without a family history may also be asked for permission to contact parents or other unaffected relatives (even if they do NOT have IBD) to provide a blood sample.

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Characterization of the Intestinal Microbiome in Patients with and without PSC

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing

Objective: The objective is to assess the composition of the microbiome in patients with and without PSC, IBD patients without PSC (Ulcerative colitis and colonic Crohn’s disease) and healthy controls.
Expectation: This research may lead to a better understanding of why the disease occurs and what role the gut microbiome and other markers play in PSC and/or IBD.
Eligibility: Anyone who has a confirmed diagnosis of Primary Sclerosing Cholangitis and/or IBD (either Crohn's Disease or Ulcerative Colitis). Also, if you do not have IBD (i.e. Crohn's Disease or Ulcerative colitis) and do not have a family history of IBD and are willing to participate as a healthy control, your help would be greatly appreciated.

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 a 4-day food diary prior to your sample collection
  • If you are scheduled to have a colonoscopy already as part of your routine clinical care, you may be asked if you're willing to provide tissue biopsies for research purposes during your colonoscopy
  • If you are willing, you may be asked to provide a stool sample which can be collected at home
• All study supplies are provided by us.
• You may not have to see any physicians at Mount Sinai Hospital, if you are not already scheduled to have a colonoscopy performed by your physician.

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

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Diet intervention as a prebiotic treatment for active ulcerative colitis
Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg
Enrolment: Ongoing

Sponsor: National Institute Health

Objective: To determine if a sustainable non-elemental diet can affect the severity of active Ulcerative Colitis (UC) by altering the microbiome.

Eligibility: Any Mount Sinai Hospital (MSH) patient who has a confirmed diagnosis of Ulcerative Colitis. Patients must be willing to consume an 8-week study diet provided to them and willing to undergo 2 colonoscopies, 10 weeks apart. Patients must also be on a stable dose of medication for a minimum of a month prior to enrollment.

You are NOT eligible for this study if:

• You do not have confirmed diagnosis of Ulcerative Colitis
  
• You are currently in endoscopic remission
  
• You plan on changing medications or treatment options for Ulcerative Colitis
  
• You are planning on changing your smoking habits

 
Participation:
Participation involves:  
•    Providing the study team with information regarding your family history and disease activity
•    Providing us with permission to review your medical information regarding IBD
•    Consuming study meals designed by a dietician and produced by a professional chef for 8 weeks
•    Undergoing 2 endoscopies, 10 weeks apart
•    Filling in 3-day food diaries prior to your sample collections and a food frequency diary before beginning
•    Providing stool and blood samples intermittently throughout the study (every 2 weeks)
•    Allowing us to follow you for 10 weeks

Background information:
Environmental factors like microbiome and diet play a significant role in the risk of Ulcerative colitis (UC), a type of Inflammatory Bowel Disease (IBD) involving the large intestine. Individuals with UC may have an overall lower gut bacteria (microbiome) diversity and a reduced quantity of certain types gut bacteria. This is thought to affect the permeability of the intestinal barrier and influence gut inflammation. Therefore, altering the microbiome of UC patients may have a positive effect on disease activity by reducing inflammation. A high protein and low fiber diet may be linked to intestinal inflammation, onset of symptoms and flares. A sustainable non-elemental diet consisting of low protein and high fiber foods, is used as a probiotic tool in our study to modify the gut bacteria in individuals with IBD. The goal of this study is to have a better understanding of how the microbiome is influenced by diet and to set the groundwork for a clinically validated diet for IBD patients.

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

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Tissue (Biopsy) collections, Stool collections and Dietary Information (Food Diaries) for IBD studies
Contact: Joanne Stempak, Project Manager 416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg
Enrolment: Ongoing

Objective: The objective is to understand how diet and other biomarkers may affect the gut microbiome in IBD.
Expectation: This research will lead to a better understanding of why the disease occurs, easier diagnostic tools that may avoid the need for colonoscopies, better therapies or even a cure.
Eligibility: Anyone who has a confirmed diagnosis of IBD (either Crohn's Disease or ulcerative colitis) and has a scheduled colonoscopy for their routine care. Also, anyone who does not have IBD (i.e. Crohn's Disease or ulcerative colitis) or have a family history of IBD, has a scheduled colonoscopy and is willing to participate as a healthy control.
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 a 4-day food diary prior to your sample collection and scheduled colonoscopy
  • If you are scheduled to have a colonoscopy already as part of your routine clinical care, you may be asked if you're willing to provide tissue biopsies for research purposes during your colonoscopy
  • If you are willing, you may be asked to provide a stool sample which can be collected at home
• All study supplies are provided by us.
• You may not have to see any physicians at Mount Sinai Hospital, if you are not already scheduled to have a colonoscopy performed by your physician.

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

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Genetic Analysis of Infliximab-treated Inflammatory Bowel Disease Patients
Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing

Objective: The objective is to identify differentially expressed genes between responders and non-responders to Infliximab therapy and to examine if significant gene expression differences exist between Infliximab-treated ulcerative colitis and Crohn’s Disease patients.
Expectation: This research will lead to a better understanding of why some people respond well to Infliximab and why others may not respond as well. This may lead to a better understanding of Crohn’s disease and ulcerative colitis and possibly help doctors decide if someone should start Infliximab therapy.
Eligibility: Anyone over the age of 18 who has a confirmed diagnosis of IBD (either Crohn's Disease or ulcerative colitis) and is about to start Infliximab in the near future (for the first time) and scheduled for a colonoscopy PRIOR to their first infusion. If you’re taking steroids, you must have been on oral steroids for at least 2 weeks or 7 days for intravenous steroids and be on a stable dose for at least one week prior to study start.
You are not eligible for this study if:

• You’ve had a prior history of colectomy
• You are pregnant
• You have been on Infliximab before
• You have an infection or inflammation not associated with IBD.

Participation: Participation involves:

• Providing us with information regarding your family history and disease specifics
• A blood sample for research purposes
• Providing us with permission to review your medical information regarding IBD
• If you are scheduled to have a colonoscopy already as part of your routine clinical care, you may be asked if you're willing to provide tissue biopsies for research purposes during your colonoscopy
• Allowing us to follow you for up to 30 weeks after your first infusion with data and samples collected at the time of your routine check ups with your gastroenterologist. 

Background information:
Tumour necrosis factor-alpha blocking agents encompass some of the available therapies for Inflammatory Bowel Disease patients. Infliximab is one of the most popular and effective amongst them and is used in both Crohn’s Disease and Ulcerative colitis. Studies show that the majority of Inflammatory Bowel Disease patients undergoing Infliximab therapy experience beneficial effects from the drug. Nevertheless, a small number of patients experience moderate to severe adverse effects to Infliximab infusions. The potential risk for patients and the high cost of Infliximab therapy demand further research into the factors pertaining to therapy response. To date, there are no reliable predictors of Infliximab therapy outcome. With this study, we aim to identify differentially expressed genes between responders and non-responders to Infliximab therapy and to examine if significant gene expression differences exist between Infliximab-treated Ulcerative colitis and Crohn’s Disease patients.
We would like to sincerely thank all of our study participants. This research couldn't be possible without your cooperation.

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Mechanisms of Intestinal Inflammation Following Ileal Resection for Crohn's Disease

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399


Primary Investigator: Dr. Mark Silverberg


Enrolment: Ongoing 

Sponsor: This initiative is funded by the Crohn’s and Colitis Foundation of Canada

Objective: The objective is to evaluate microbial and gene expression factors which are associated with the recurrence of small bowel inflammation following surgery for Crohn’s Disease. This will have practical implications for evaluating which patients are more likely to rapidly recur as well as provide insight into the pathogenesis of Crohn’s Disease.

Eligibility: Any Mount Sinai Hospital (MSH) patient who has a confirmed diagnosis of Crohn's Disease with disease located in the ileum or terminal ileum and undergoing ileal, ileocecal or ileocolonic resection at MSH for the first time at the time of study enrolment.

You are not eligible for this study if:

• You’ve had a prior resection surgery or have undergone strictureplasty

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 prior to your sample collections
• Allowing us to follow you for up to 18 months after your surgery with data and samples collected at the time of your routine check ups with your gastroenterologist or surgeon. 
• If you are scheduled to have a colonoscopy as part of your routine clinical care, you may be asked if you're willing to provide tissue biopsies for research purposes during your colonoscopy
   

Background information:
For many Crohn's Disease patients with small portions of severely affected terminal ileum, surgical removal of the diseased bowel and reconnection of the two ends is considered a reasonable treatment option. However, patients may experience recurrence of their disease in the future following surgery. Similar to hypotheses regarding the development of Crohn’s Disease, those relating to the recurrence of inflammation following surgery suggest that inflammation is the result of altered immunity in genetically predisposed individuals due to a combination of changes in gene expression and the microbial milieu. The aim of this study is to evaluate microbial and gene expression factors which are associated with the recurrence of small bowel inflammation following surgery for CD. This will have practical implications for evaluating which patients are more likely to rapidly recur as well as provide insight into the pathogenesis of Crohn’s Disease.

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

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

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399



Primary Investigator: Dr. Mark Silverberg


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.

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The UC Relapse Study: Gene expression profiles and microbial predictors of relapse in Ulcerative Colitis

Contact: Joanne Stempak, Project Manager
416-586-4800 ext 8399



Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing 

Sponsor:  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Objective:  To evaluate the genetic, microbial and other factors associated with remission and relapse in patients with Ulcerative Colitis (UC).

Eligibility: Any Mount Sinai Hospital (MSH) patient who has a confirmed diagnosis of Ulcerative Colitis in clinical and endoscopic remission. Patients must also be on a stable dose of medication for a minimum of a month prior to enrollment.

You are not eligible for this study if:

• You do not have confirmed diagnosis of Ulcerative Colitis
• You are not in endoscopic or clinical remission
• You plan on changing medications or treatment options for Ulcerative Colitis

  Participation:
Participation involves:  

• Providing the study team with information regarding your family history and disease activity
• A small blood sample for research purposes
• Providing tissue biopsies for research purposes during your colonoscopy
• Providing us with permission to review your medical information regarding IBD
• Filling in 4-day food diaries prior to your sample collections
• Providing stool samples intermittently throughout the study
• Allowing us to follow you for up to 24 months after enrollment into the study with data and samples collected at the time of your routine checkups with your gastroenterologist

Background information:
Ulcerative colitis (UC) is a chronic inflammatory condition involving the large intestine. In most cases, the disease course is characterized by periods of flares (when patients experience symptoms of diarrhea, urgency, abdominal pain, and/or blood in the stool) and periods of remission (when there are no, or very few, symptoms of active inflammation). The presence or absence of symptoms of active inflammation generally correspond to inflammation of the colon verified through an endoscopic evaluation. There is still very little understanding about what factors might predict which patients in remission will develop a relapse, or flare. This study hopes to understand the role of genetic and microbial factors during a flare in order to better predict flare and remission of UC. We would like to sincerely thank all of our study participants. This research couldn't be possible without your cooperation.

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