Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome.
Norman R Harden, Stephen Bruehl, Roberto S G M Perez...
https://pubmed.ncbi.nlm.nih.gov/20493633Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID03612193
Role of the Gut Microbiome in Complex Regional Pain Syndrome
Led by Washington University School of Medicine · Updated on 2025-11-05
140
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the role of the gut microbiome in Complex Regional Pain Syndrome (CRPS) through two related, observational studies. Study A aims to understand how differences in gut bacteria and metabolites relate to the severity and persistence of CRPS symptoms in people with acute or chronic CRPS. Study B focuses on newly diagnosed CRPS patients to see if gut microbiome markers can predict who is more likely to recover. Both studies also explore how cognitive flexibility relates to patient outcomes. The studies include groups of adults with different durations of CRPS, as well as household controls. Participants include those with recent CRPS diagnosis (less than 6 months) and those with longer-term diagnoses (either less than or more than 1 year). Participants provide stool samples and undergo cognitive testing. No treatments or interventions are given as this is an observational study. The studies track changes over time, with primary outcomes measured at up to one month and at 12 months. Participants will be involved in providing stool samples for microbiome analysis and completing cognitive tests such as the Stroop Color Word Test. Researchers will analyze the relationship between microbiome differences and CRPS severity, recovery, and cognitive flexibility. The main outcomes include gut microbiome taxonomic and metabolomic differences and recovery status over 12 months. The study is sponsored by Washington University School of Medicine and is open to adults 18 years and older.
CONDITIONS
Brief Title
Role of the Gut Microbiome in Complex Regional Pain Syndrome
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults over the age of 18
- Diagnosis of Complex Regional Pain Syndrome by the Budapest criteria (current less than 1 year or former greater than 1 year for Study A)
- Recent diagnosis of Complex Regional Pain Syndrome by the Budapest criteria (less than 6 months for Study B)
- English as primary language
- Able to consent
- Cohabitant of person with current or former diagnosis of CRPS (controls)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 1 month
Participants provide stool samples and undergo assessments to evaluate the gut microbiome in relation to Complex Regional Pain Syndrome (CRPS).
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are observed over time to assess changes in CRPS severity, recovery, and related factors such as cognitive function and medication use.
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
L
Lara Crock, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Published Research Related To This Trial
Complex regional pain syndrome-up-to-date.
Frank Birklein, Violeta Dimova
https://pubmed.ncbi.nlm.nih.gov/29392238Complex regional pain syndrome - phenotypic characteristics and potential biomarkers.
Frank Birklein, Seena K Ajit, Andreas Goebel...
https://pubmed.ncbi.nlm.nih.gov/29545626Local cytokine changes in complex regional pain syndrome type I (CRPS I) resolve after 6 months.
Melanie Lenz, Nurcan Üçeyler, Jule Frettlöh...
https://pubmed.ncbi.nlm.nih.gov/23811041Case report: Long-standing complex regional pain syndrome relieved by a cephalosporin antibiotic.
Mark A Ware, Gary J Bennett
https://pubmed.ncbi.nlm.nih.gov/24667741Identification and Treatment of New Inflammatory Triggers for Complex Regional Pain Syndrome: Small Intestinal Bacterial Overgrowth and Obstructive Sleep Apnea.
Leonard B Weinstock, Trisha L Myers, Arthur S Walters...
https://pubmed.ncbi.nlm.nih.gov/26867023Interactions between the microbiota, immune and nervous systems in health and disease.
Thomas C Fung, Christine A Olson, Elaine Y Hsiao
https://pubmed.ncbi.nlm.nih.gov/28092661Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour.
John F Cryan, Timothy G Dinan
https://pubmed.ncbi.nlm.nih.gov/22968153Disease phenotype and genotype are associated with shifts in intestinal-associated microbiota in inflammatory bowel diseases.
Daniel N Frank, Charles E Robertson, Christina M Hamm...
https://pubmed.ncbi.nlm.nih.gov/20839241The intestinal microbiota affect central levels of brain-derived neurotropic factor and behavior in mice.
Premysl Bercik, Emmanuel Denou, Josh Collins...
https://pubmed.ncbi.nlm.nih.gov/21683077