MedTrace Logo

Brain Activity and Oxygenation Inflammatory Bowel Disease (IBD) Patients

NCT04733456 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

  • IBD
  • Maladaptive Behavior Associated With Physical Illness

Interventions

BEHAVIORAL

Quality of life questionnaires

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

DEVICE

NIRS

A TechEn NIRSOptix continuous-wave fNIRS system will be used to record changes in cerebral oxygenation, at a sampling rate of 25 Hz

OTHER

Stool Collection

For assessment of the known biomarker fecal calprotectin, in addition to fecal bacterial and fungal microbiome

OTHER

Blood and urine collection

for inflammatory markers and metabolomic \[IMC\] analysis

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Mark Swain, MD · University of Calgary

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2025-01-05
Completion
2026-01-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733456 on ClinicalTrials.gov