Status:
UNKNOWN
Brain Activity and Oxygenation Inflammatory Bowel Disease (IBD) Patients
Lead Sponsor:
University of Calgary
Conditions:
IBD
Maladaptive Behavior Associated With Physical Illness
Eligibility:
All Genders
18-85 years
Brief Summary
Symptoms such as fatigue, sleep disturbances, anxiety and depression are common in patients with IBD, but the cause is unknown. Understanding how these behaviors occur in IBD and their role in symptom...
Detailed Description
Hypothesis Conditions with acute systemic inflammation will correlate with changes in gut microbiome signatures, reduced cerebral oxygen saturation (StO2) and altered patterns of microvascular cerebra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 5 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04733456
Start Date
April 26 2021
End Date
January 5 2026
Last Update
April 28 2021
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6