Health TrialsbyHealthPanel

Role of the Gut Microbiome in Complex Regional Pain Syndrome

ConditionComplex Regional Pain Syndromes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Pain Management Center at Washington University/Barnes-Jewish Hospital medical campus

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 5 trial groups
Group A: Study A: Chronic >1 year
Group B: Study A: Acute <1 year
Group C: Study A: Household Control
Group D: Study B: Newly Diagnosed <6 months
Group E: Study B: Household Controls

Trial outcomes

Primary outcomes

1

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
2

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

1

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

Study B

Time frame
12 months
2

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
3

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

Study B

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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