Role of the Gut Microbiome in Complex Regional Pain Syndrome

Washington University School of Medicine140 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

140

Conditions

Complex Regional Pain Syndromes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Study A: Cross-sectional study Inclusion criteria, cases: * Adults over the age of 18 * Current (\< 1 year duration) or former (\> 1 year) diagnosis of Complex Regional Pain Syndrome by the Budapest criteria * English as primary language * able to consent Inclusion criteria, controls * Adults over age of 18 * Cohabitant of person with current or former diagnosis of CRPS Study B: Longitudinal Study Inclusion criteria, cases: * Adults over the age of 18 * Recent diagnosis (\<6 months) of Complex Regional Pain Syndrome by the Budapest criteria * English as primary language * able to consent Inclusion criteria, controls * Adults over age of 18 * Cohabitant of person with diagnosis of CRPS Study A and B: Exclusion criteria, cases and controls: * Unwilling to participate in the study * Lives alone * Current use of probiotics and unwilling to stop for 1 week prior to stool sample * Pregnant or lactating * Vegan diet

Outcomes

Primary Outcomes

Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score

Study A

Time frame: 1 visit - up to one month

Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS

Study B

Time frame: 12 months

Secondary Outcomes

Score results of the Stroop Color Word Test in relation to CRPS recovery

Study B

Time frame: 12 months

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)

Study B

Time frame: 12 months

Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics

Study B

Time frame: 12 months

Role of the Gut Microbiome in Complex Regional Pain Syndrome

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts