Evaluation of Brain Activity and Oxygenation Using Near-infrared Spectroscopy (NIRS) in Inflammatory Bowel Disease (IBD) Patients

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Device
Study Type: Observational
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 symptoms may help improve management of IBD. How IBD leads to changes in brain function remains unclear. Inflammation and dysfunction of blood flow may occur in patients with IBD, which may be linked to these symptoms. Patients with IBD also have an alteration or imbalance of gut bacteria which may play a role in the development of the disease, but the exact mechanism remains poorly understood;as a result, there are limited therapeutic options available clinically to address this issue. An approved therapy, anti-TNF α, may be useful in improving brain and gut activity as well as quality of life. The purpose of this research study is to better understand brain and gut activity in the context of IBD to possibly improve treatments for the disease. In patients taking anti-TNFα therapy as prescribed clinically as standard of care, the investigators will measure brain activity using NIRS; gut microbiome using stool analysis and quality of life using various questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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⁃ 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).

Locations
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Mark G Swain, MD
swain@ucalgary.ca
403-592-5010
Backup
Pam Crotty
pcrotty@ucalgary.ca
403-592-5076
Time Frame
Start Date: 2021-04-26
Estimated Completion Date: 2026-01-05
Participants
Target number of participants: 40
Treatments
IBD Patients (UC and CD)
Participants will complete a Mayo Clinic Score (UC) or HBI score (CD), short IBDQ73, \*EQ5D-5L, \*GAD-774, \*PHQ-975, \*PROMIS (Gastrointestinal Belly Pain), Multidimensional Assessment of Interoceptive Awareness (MAIA)77, \*Pain Catastrophizing Scale, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS) at baseline and 16 weeks after the start of anti-TNF therapy (\*questionnaires available through the CIHR IMAGINE grant).~Stool will be collected at baseline and after 16 weeks for assessment of the known biomarker fecal calprotectin, in addition to fecal bacterial and fungal microbiome (through the International Microbiome Center \[IMC\], U of C). Blood will be drawn and urine collected at baseline and after 16 weeks for inflammatory markers and metabolomic \[IMC\] analysis
Related Therapeutic Areas
Sponsors
Leads: University of Calgary

This content was sourced from clinicaltrials.gov