Role of the Gut Microbiome in Complex Regional Pain Syndrome
Recruiting
- Conditions
- Complex Regional Pain Syndromes
- Registration Number
- NCT03612193
- Lead Sponsor
- Washington University School of Medicine
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score 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 12 months Study B
- Secondary Outcome Measures
Name Time Method Score results of the Stroop Color Word Test in relation to CRPS recovery 12 months Study B
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 Study B
Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics 12 months Study B
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States