Role of the Gut Microbiome in Complex Regional Pain Syndrome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03612193

Enrollment

140

Registered

2018-08-02

Start date

2018-12-19

Completion date

2027-07-31

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndromes

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS	12 months	Study B
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

Secondary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactLara Crock, MD PhD

crockl@wustl.edu314-546-3882

Outcome results