Nestle Epsilon Study: A Randomized, Double-Blind, Placedo Controlled Trial to Evaluate the Effects of Bifidobacterium longum on Instestinal and Psychological Symptoms in Subjects with Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder that occurs in around 11% of the global population and is characterized by recurring belly pain and changes in bowel habits. Patients with IBS have often psychological symptoms, such as low mood and anxiety. This study is evaluating the effects of a probiotic, Bifidobacterium longum, on intestinal and psychological symptoms in subjects with Irritable Bowel Syndrome (IBS).

Fecal Microbial Therapy in Ulcerative Colitis
This project will use antibiotic pre-treatments to see if the success of fecal microbial therapy (FMT) is improved in patients with ulcerative colitis (UC).

Fecal Microbial Therapy in Crohn’s Disease
This project will determine whether fecal microbial therapy (FMT) can improve symptoms in patients with Crohn’s disease (CD).

PET Imaging Study
This study will be brain scanning patients with IBD who are also clinically depressed to better understand how the two relate to each other.

Cognitive Behavioural Therapy for Mental Health
Depression and anxiety are highly prevalent in people diagnosed with inflammatory bowel disease (IBD), with depression rates almost twice as high for those with IBD compared to the general community, and an estimated 20% overall with depression or anxiety. Perceived stress is a factor in the development of anxiety and depression. These comorbid conditions complicate management of IBD, adversely impacting patient outcomes and health, and increasing the resource burden to the health care system. However, comorbid depression and anxiety in IBD patients is undertreated, paralleling unmet mental health treatment needs in the general Canadian population. Development of alternate modes of effective treatment delivery is vital to enhance access, given limited mental health service availability. Cognitive behavioural therapy (CBT) has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses. There is some evidence that CBT can be successfully delivered as an internet-based intervention. While there are limited data on the efficacy of CBT tailored to the IBD population, studies targeting comorbid depression in IBD have resulted in significant mental health improvement. A recent study implementing an internet-based CBT program for IBD reported modest outcomes, but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms.

The internet-based program used in this study will involve brief modules focused on areas important in managing stress, anxiety and depression including:

Core Topics

1. About the Program, 2. IBD and Stress, 3. Relaxation Strategies, 4. Commitment to Living Life Fully, 5. The Brain-Gut Connection, 6. Understanding Anxiety, 7. Overcoming Avoidance, 8. Depression, 9. Behavioural Activation

Low FODMAPS Diet in Irritable Bowel Syndrome
This project will determine whether a low FODMAP diet can improve symptoms in IBS patients

Patient Preferences in Inflammatory Bowel Disease Treatments
This study will help us understand what is important to people with inflammatory bowel disease (IBD) when choosing between treatments.

*Please note: Currently, we are only recruiting subjects that are residents of Alberta or Manitoba and enrolled in the IMAGINE main cohort study (MInd and Gut Interactions Cohort (MAGIC)).

Stress reduction in IBD
This study will use an online stress reduction program to help people with inflammatory bowel disease (IBD) identify and manage stressors. More information can be found at: www.wellnesstoolbox.ca/intro

Biomarkers of Diet-Microbiota Interactions in IBS
This study will identify biomarker(s) to guide the dietary management of IBS patients and possible new treatments.

Patient information sheet – TBD
Eligibility Requirements – TBD

FMT in Pouchitis
The primary objective of this study is to determine if using stool from a healthy donor (fecal transplantation) can improve symptoms in patients with pouchitis. Patients with pouchitis can often get symptoms of diarrhea and abdominal pain. We are interested to see if these types of symptoms improve more often in patients treated with stool from a healthy donor compared to placebo.

Patient information sheet – TBD
Eligibility Requirements – TBD

Mental Health Assessment in routine IBD Care
Crohn’s disease and ulcerative colitis, known collectively as inflammatory bowel disease (IBD) are among the most common chronic diseases managed by GIs. Anxiety and mood disorders (AMDs) are more common in persons with IBD than they are in the general population. Persons with AMDs tend to have a higher symptom burden with their IBD. In spite of the impact that AMDs have on the disease experience and quality of life of persons with IBD, there is not a standard approach for how GIs should identify AMDs in their IBD patients, and how patients with AMDs can be directed to appropriate therapies. GIs do not receive specific training in how to diagnose and manage AMDs, and thus may be reticent to engage with AMDs in this population. We are hoping to determine whether GIs proactively identify symptoms of AMD in their symptomatic IBD patients, and to perform qualitative research to identify barriers to addressing AMD symptoms in their IBD patients

Patient information sheet – TBD
Eligibility Requirements – TBD

FMT in population with Major Depressive Disorder & IBS
This study will build on the opportunity provided by a funded study at the University of Calgary which looks at the impact of fecal microbiota transplantation (FMT) on depression. Given that there are high rates of IBS in individuals with depression, we propose to take advantage of the research team and processes already established to add an additional study arm to our trial, examining the impact of FMT on both mood and gastrointestinal (GI) symptoms in patients with IBS and depression. Participants will receive either FMT capsules or placebo once weekly for 12 weeks and their mood and GI symptoms will be monitored. We will also analyze their blood and stool and obtain brain x-rays to try to understand how FMT causes changes.

Patient information sheet – TBD
Eligibility Requirements – TBD

Effect of Resilience, Childhood Trauma on Suicidal Ideation in IBD
IBD is associated with depression and suicidal ideation (SI). Childhood trauma and resilience are associated with both depression and suicide risk. No research examines these variables in adult IBD. Patients who suicide visit physicians 2X often as mental-health clinicians. Physicians are trained in treating mental illness, but are uncomfortable managing suicide risk. This study examines how variables for IBD suicide risk can be better understood and thus managed. Patients will complete online surveys regarding demographic (age, gender), medical (pain, disease activity), and psychological variables (childhood trauma, depression, suicide risk, resilience). This new research is important because it may aid in management of suicide risk in patients with IBD and inform treatment thereof.

Patient information sheet – TBD
Eligibility Requirements – TBD

You Are What You Eat: Can Previous Diet Predict Response to Therapy
The questions most frequently asked by patients with IBS and IBD relate to the role of diet. Unfortunately, evaluating diet and its role is difficult with limited high-quality scientific research available. Although some children with Crohn’s disease respond to special diets, these are difficult treatments and we just can’t predict who will and who won’t respond.
Using data from the Canadian Children IBD Network (CCIBDN) we have shown that patients’ previous diets can predict their response to dietary therapy. We think that bacteria in the gut are responsible for this effect and have designed a study to test this. We will use stool collected from CCIBDN patients, as well as patients on a new diet study for children with Crohn disease. We will also use data/samples from IMAGINE to confirm our findings. Together, this research will teach us about how diet affects IBD, which could lead to new, better treatments.

Patient information sheet – TBD
Eligibility Requirements – TBD