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

McGill University logo

McGill University

Status

Active, not recruiting

Conditions

CRPS

Treatments

Diagnostic Test: Stool and blood samples
Other: Questionnaires
Other: Physical examination

Study type

Observational

Funder types

Other

Identifiers

NCT05473338
CRPS-MB 2021-6735

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

250 participants in 2 patient groups

CRPS (Complex Regional Pain Syndrome)
Description:
Participants with CRPS (Complex Regional Pain Syndrome))
Treatment:
Diagnostic Test: Stool and blood samples
Other: Physical examination
Other: Questionnaires
Healthy
Description:
Healthy individuals
Treatment:
Diagnostic Test: Stool and blood samples
Other: Questionnaires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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