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Completed

NCT Number: NCT03487926

Microglial Activation in Inflammatory Bowel Disease

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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 :

  • 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.
  • The neuroinflammation (TSPO VT) in PFC, ACC, and insula regions will be reduced after treatment for IBD.

The Secondary Hypothesis:

  • Elevations in neuroinflammation (TSPO VT) will be similar in those with ulcerative colitis and Crohn's disease.
  • Neuroinflammation (TSPO VT) will be greater in IBD with depression than in depression without IBD.
  • Biologics (TNFalpha antibody treatments), and fecal transplantation will be associated with greater reduction in neuroinflammation in brain than Sulfasalazine/5-Aminosalicylates.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 65
  • aside from IBD groups and common comorbidities of IBD, otherwise good physical health with no current active medical conditions.
  • a lifetime diagnosis of IBD verified by medical record, which can include prescription for IBD treatment

Exclusion criteria

  • no history of neurological illness, excluding migraine
  • no use of glucocorticoid antagonists or lithium or medications that bind with affinity higher than 500nM to peripheral benzodiazepine receptors (or TSPO) in the previous two months
  • no use of herbal remedies in the previous month that would be expected to influence neuroinflammation
  • non-cigarette smoking
  • no history of abuse of substances that affect mood and negative urine drug screens for substances of abuse including cotinine (urine drug screen is done at screening and on each PET scan day)
  • no history of psychotic symptoms
  • not pregnant based on a negative pregnancy test (for women)
  • not breastfeeding (for women)
  • no recent treatment with electroconvulsive therapy or magnetic seizure therapy in the previous 6 months
  • no coagulation disorders, or anticoagulant medication use
  • no presence of metal objects or implanted electrical devices in the body that would preclude MRI scanning
  • no claustrophobia
  • no self-reported history of fainting from blood withdrawals
  • size and weight does not exceed capacity of scanner, for which size may vary and weight is 350 lbs
  • no history of undergoing a number of PET scans that, including the number of PET scans under this protocol, will bring the total to more than 8 PET scans/lifetime, exceeding permissible limit for subjects participating in research set by our centre's guidelines

Treatment and study plan

[18F]FEPPA

Radiation

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

Primary outcomes

  1. TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula

    Time frame: within 3 to 4 weeks after initiation of screening

    Between group comparison for 3 regions in IBD compared to controls (analysis done concurrently for group effect across 3 regions)

  2. change in TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula before and after 3 to 6 months

    Time frame: 3 to 6 months

    Change in TSPO VT for three regions (same units for each region)

  3. MAO-B VT in prefrontal cortex, anterior cingulate cortex, insula in IBD compared to controls

    Time frame: within 3 to 4 weeks after initiation of screening

    Between group comparison for 3 regions in IBD compared to controls

Secondary outcomes

  1. TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between Crohns disease and ulcerative colitis

    Time frame: within 3 to 4 weeks of initiating screening of subjects

    comparison of TSPO VT in 3 regions between two types of inflammatory bowel disease

  2. TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between IBD with MDE compared to MDE controls

    Time frame: within 3 to 4 weeks after initiation of screening

    Between group comparison for 3 regions in IBD compared to controls

  3. change in TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between naturalistic treatment with sulfasalazine/5-aminosalicylates versus other interventions like biologics or fecal transplantation

    Time frame: 3 to 6 months

    differential change in TSPO VT across 3 regions before and after 6 months in those receiving naturalistic treatment with sulfasalazine/5-aminosalicylates versus other naturalistic treatments of fecal transplantation or biologics

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • McMaster University

Registry information

Official study title

Naturalistic Monitoring of Microglial Activation in Inflammatory Bowel Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2018
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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