Understanding Brain Activity and Oxygen Levels in IBD Patients
Evaluation of Brain Activity and Oxygenation Using Near-infrared Spectroscopy (NIRS) in Inflammatory Bowel Disease (IBD) Patients
University of Calgary · NCT04733456
This study is trying to see how brain activity and oxygen levels relate to symptoms like fatigue in people with Inflammatory Bowel Disease (IBD).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04733456 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between brain function, oxygenation, and symptoms in patients with Inflammatory Bowel Disease (IBD). It utilizes near-infrared spectroscopy (NIRS) to measure changes in brain blood perfusion and oxygen saturation, which may correlate with symptoms like fatigue and cognitive impairment. The study will also assess gut microbiome signatures and their potential link to brain activity. By investigating these connections, the research seeks to improve treatment strategies for IBD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with moderate-to-severe ulcerative colitis or Crohn's disease who are eligible for anti-TNF therapy.
Not a fit: Patients with severely active IBD requiring high doses of prednisone or those with severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for IBD by understanding the interplay between gut health and brain function.
How similar studies have performed: While the approach using NIRS is innovative, similar studies exploring the gut-brain axis in IBD have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible patients will be: * \> 18 years of age with moderate-to-severe UC or (partial Mayo score \[excluding endoscopy\] ≥5 with rectal bleeding subscore ≥1; or total Mayo subscore 6-12 with RBS ≥1) or CD (Harvey-Bradshaw index \[HBI\] of 7 or greater, and active CD confirmed on POC bowel ultrasound (defined by bowel wall thickness \>3mm and positive Color doppler signal and a fecal calprotectin \> 50 μg/g ). * based on their active disease status patients cannot be taking \> 20 mg prednisone daily and * must be eligible for anti-TNF therapy as per standard of care (clinical decision made by IBD specialist caring for the patient). Exclusion Criteria: * patients with severely active UC (clinical signs of fulminant colitis or toxic megacolon) or CD (HBI \> 16), requiring \> 20 mg of prednisone daily at induction, suicidal ideation or psychosis.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Mark Swain, MD — University of Calgary
- Study coordinator: Mark G Swain, MD
- Email: swain@ucalgary.ca
- Phone: 403-592-5010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IBD, Maladaptive Behavior Associated With Physical Illness