Complex Regional Pain Syndrome (CRPS) and the Gut-bacteria

CRPS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05473338
• Other study ID #: CRPS-MB 2021-6735
• Status: Active, not recruiting
• Start date: April 14, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CRPS

Intervention

Diagnostic Test:
• Stool and blood samples
fecal microbiome and metabolomics, as well as metabolites in plasma

Other:
• Physical examination
physical examination performed by a physician to confirm CRPS diagnosis and assess patient's eligibility to participate in the study. The exam will include skin temperature measured using a laser/infrared skin thermometry.
• Questionnaires
Questionnaires measuring pain level, sleep, mood and diet parameters.

Locations

Country	Name	City	State
Canada	Alan Edwards Pain Management Unit - Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Louise and Alan Edwards Foundation, Rambam Health Care Campus

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiome composition	Assessment of genomic composition of the gut bacteria by differential abundance analysis will be performed using 16S rRNA (Genome-Quebec)	1 day
Primary	Presence of stool microbiota-related metabolites affecting host physiology	Concentration of bile acids and short-chain-fatty-acids through Metabolomics analysis (Metabolon, USA).	1 day
Secondary	Short-form health-questionnaire (SF12) score	A 12-item measure of health-related quality of life, validated in a variety of population groups	1 day
Secondary	Brief Pain Inventory (BPI) score	A 12-item questionnaire evaluating function level and disability among pain patients	1 day
Secondary	Patient Health Questionnaire (PHQ-9) score	A 9 item inventory rated on a 4 point Likert-type scale used for screening for depression and anxiety	1 day
Secondary	Pittsburg Sleep Quality Index (PSQI) scores	A standardized self-administered questionnaire for the assessment of subjective sleep quality	1 day