Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT04733456

Conditions

IBD

Maladaptive Behavior Associated With Physical Illness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Quality of life questionnaires

NIRS

Stool Collection

Blood and urine collection

Study Details

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 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

Study ID

NCT04733456

Start date

Apr 26, 2021

Status verified date

Nov, 2020

Completion date

Jan 5, 2026

Anticipated

Primary completion date

Jan 5, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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

NIRS

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

Stool Collection

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

Blood and urine collection

for inflammatory markers and metabolomic \[IMC\] analysis

Primary outcome measure

  • a) Clinically: CD (decrease of >3 points in the modified Harvey-Bradshaw Index); UC (decrease of >2 points in the partial Mayo Score) [ Time Frame: 16 weeks ]
  • b) Radiographically: decrease in bowel wall thickness ≥25% in most affected segment with 2 point decrease in color Doppler signal score or normalization [ Time Frame: 16 weeks ]
  • c) Biomarker: decrease in fecal calprotectin >50% from baseline or ≤250 ug/g [ Time Frame: 16 weeks ]
  • d) Endoscopically (where available): CD (decrease in Simple Endoscopic Score for CD ≥50% from baseline); UC (decrease in Mayo endoscopic subscore ≥1 point from baseline) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Mark G Swain, MD

403-592-5010swain@ucalgary.ca

Pam Crotty

403-592-5076pcrotty@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Blessing Odia

403-220-5782

More Information

Sponsor

University of Calgary

Last update posted

Apr 28, 2021

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-04-28.