Clinical trial NCT05473338: Complex Regional Pain Syndrome (CRPS) and the Gut-bacteria
Official title: Comparison of Gut Microbial Composition and Function in CRPS Patients vs. Healthy Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CRPS
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Louise and Alan Edwards Foundation
name: Rambam Health Care Campus
First posted: 2022-07-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women and men with CRPS and healthy volunteers.

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.


Eligibility criteria: Inclusion criteria:

1. Women and men over the age of 18, diagnosed with CRPS of the upper or lower limb according to the Clinical Budapest Criteria, with a duration of 6 months and over (for the 1st study group).
2. Healthy women and men over the age of 18, who share a household with a CRPS patients participating in the study (for the 1st control group).
3. Healthy women and men over the age of 18 (for the 2nd control group).
4. Be able to read and write in either French, English or Hebrew.

Exclusion criteria:

1. Any major illness (eg. malignancy, active inflammatory disease, metabolic disease, etc.)
2. Pregnancy
3. Chronic pain conditions (other than CRPS in the patients group)
4. Acute illness of any type in the preceding 1 month
5. Use of systemic antibiotics in the preceding 1 month
6. Change in any other regularly taken medications in the past 1 month
7. Substantial dietary / gastrointestinal alterations in the past 1 month.

The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition.

Primary outcomes:
measure: Gut microbiome composition
timeFrame: 1 day
measure: Presence of stool microbiota-related metabolites affecting host physiology
timeFrame: 1 day
Secondary outcomes:
measure: Short-form health-questionnaire (SF12) score
timeFrame: 1 day
measure: Brief Pain Inventory (BPI) score
timeFrame: 1 day
measure: Patient Health Questionnaire (PHQ-9) score
timeFrame: 1 day
measure: Pittsburg Sleep Quality Index (PSQI) scores
timeFrame: 1 day
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Alan Edwards Pain Management Unit - Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Yoram Shir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birklein F, Ajit SK, Goebel A, Perez RSGM, Sommer C. Complex regional pain syndrome - phenotypic characteristics and potential biomarkers. Nat Rev Neurol. 2018 May;14(5):272-284. doi: 10.1038/nrneurol.2018.20. Epub 2018 Mar 16.
citation: Birklein F, O'Neill D, Schlereth T. Complex regional pain syndrome: An optimistic perspective. Neurology. 2015 Jan 6;84(1):89-96. doi: 10.1212/WNL.0000000000001095. Epub 2014 Dec 3.
citation: Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med. 2007 May-Jun;8(4):326-31. doi: 10.1111/j.1526-4637.2006.00169.x.
citation: Minerbi A, Gonzalez E, Brereton NJB, Anjarkouchian A, Dewar K, Fitzcharles MA, Chevalier S, Shir Y. Altered microbiome composition in individuals with fibromyalgia. Pain. 2019 Nov;160(11):2589-2602. doi: 10.1097/j.pain.0000000000001640.