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Clinical Trials/NCT05473338
NCT05473338
Active, not recruiting
Not Applicable

Comparison of Gut Microbial Composition and Function in CRPS Patients vs. Healthy Individuals

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country250 target enrollmentApril 14, 2022
ConditionsCRPS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CRPS
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
250
Locations
1
Primary Endpoint
Gut microbiome composition
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to investigate, for the first time, whether gut bacteria composition and function of patients with CRPS differ from those of healthy adults. Samples of stool, urine and blood will be collected from patients with CRPS and from healthy adults. The type and function of bacteria of CRPS patients will be analyzed and compared to those of healthy adults to test if potential differences could explain the mechanism/s involved with the development of CRPS.

Registry
clinicaltrials.gov
Start Date
April 14, 2022
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Dr. Yoram Shir

Director, the Alan Edwards Pain Management Unit

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gut microbiome composition

Time Frame: 1 day

Assessment of genomic composition of the gut bacteria by differential abundance analysis will be performed using 16S rRNA (Genome-Quebec)

Presence of stool microbiota-related metabolites affecting host physiology

Time Frame: 1 day

Concentration of bile acids and short-chain-fatty-acids through Metabolomics analysis (Metabolon, USA).

Secondary Outcomes

  • Pittsburg Sleep Quality Index (PSQI) scores(1 day)
  • Short-form health-questionnaire (SF12) score(1 day)
  • Brief Pain Inventory (BPI) score(1 day)
  • Patient Health Questionnaire (PHQ-9) score(1 day)

Study Sites (1)

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