Clinical trial NCT03612193: Role of the Gut Microbiome in Complex Regional Pain Syndrome
Official title: Role of the Gut Microbiome in Complex Regional Pain Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pain Management Center at Washington University/Barnes-Jewish Hospital medical campus

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).


Eligibility 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

Primary outcomes:
measure: Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score
timeFrame: 1 visit - up to one month
measure: Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS
timeFrame: 12 months
Secondary outcomes:
measure: Score results of the Stroop Color Word Test in relation to CRPS recovery
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lara Crock, MD PhD
role: PRINCIPAL_INVESTIGATOR
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