Clinical Trials Directory

Trials / Completed

CompletedNCT03487926

Microglial Activation in Inflammatory Bowel Disease

Naturalistic Monitoring of Microglial Activation in Inflammatory Bowel Disease

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
19 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to monitor microglial activation in participants with inflammatory bowel disease (IBD) and investigate the relationship that exists between these patients and their risk of acquiring major depressive episodes (MDE). Patients with both IBD and MDE will be subsequently approached to participate in the study.

Detailed description

Detailed Description: Participants may undergo up to 3 PET Scans : \[18F\]FEPPA PET (for TSPO) before and 3 to 6 months later and \[11C\]SL25.1188 PET (for MAO-B) as well as 1 MRI scan. The primary hypothesis is that : 1. The neuroinflammation (TSPO VT) will be increased in PFC, ACC, and insula regions in those with inflammatory bowel disease (IBD) patients compared to healthy people. 2. The neuroinflammation (TSPO VT) in PFC, ACC, and insula regions will be reduced after treatment for IBD. The Secondary Hypothesis: 1. Elevations in neuroinflammation (TSPO VT) will be similar in those with ulcerative colitis and Crohn's disease. 2. Neuroinflammation (TSPO VT) will be greater in IBD with depression than in depression without IBD. 3. Biologics (TNFalpha antibody treatments), and fecal transplantation will be associated with greater reduction in neuroinflammation in brain than Sulfasalazine/5-Aminosalicylates. 4. MAO-B VT will be elevated in in the PFC, ACC, and insula in IBD compared to healthy controls. There will be no alterations to standard care of patients due to participation in the study.

Conditions

Interventions

TypeNameDescription
RADIATION[18F]FEPPAup to 3 PET Scans (\[18F\]FEPPA PET scans done 3 to 6 months apart, and one \[11C\]SL2511.88 PET scan) and 1 MRI

Timeline

Start date
2022-09-14
Primary completion
2024-11-19
Completion
2024-11-19
First posted
2018-04-04
Last updated
2025-04-22

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03487926. Inclusion in this directory is not an endorsement.