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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-14

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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CRPS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CRPS (Complex Regional Pain Syndrome)

Participants with CRPS (Complex Regional Pain Syndrome))

Stool and blood samples

Intervention Type DIAGNOSTIC_TEST

fecal microbiome and metabolomics, as well as metabolites in plasma

Physical examination

Intervention Type OTHER

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

Intervention Type OTHER

Questionnaires measuring pain level, sleep, mood and diet parameters.

Healthy

Healthy individuals

Stool and blood samples

Intervention Type DIAGNOSTIC_TEST

fecal microbiome and metabolomics, as well as metabolites in plasma

Questionnaires

Intervention Type OTHER

Questionnaires measuring pain level, sleep, mood and diet parameters.

Interventions

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Stool and blood samples

fecal microbiome and metabolomics, as well as metabolites in plasma

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Questionnaires

Questionnaires measuring pain level, sleep, mood and diet parameters.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes