Role of the Gut Microbiome in Complex Regional Pain Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score
Study Overview
Brief Summary
The objective of this prospective, observational study is to determine the association between the composition of the gut microbiota and the severity and persistence of Complex Regional Pain Syndrome symptoms (Study A). The objective of Study B, a longitudinal study of microbiota biomarkers of patients with newly diagnosed CRPS is to determine if the researchers can predict which patients are more likely to recover compared to those who do not. A secondary objective of both studies is to examine cognitive flexibility in relation to outcomes (study A and B).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score
Time Frame: 1 visit - up to one month
Study A
Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS
Time Frame: 12 months
Study B
Secondary Outcomes
- Logistic regression analysis for testing the association of CRPS severity score to weight in kilograms and height in meters aggregated to BMI (kilograms/meters squared)(12 months)
- Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics(12 months)
- Score results of the Stroop Color Word Test in relation to CRPS recovery(12 months)