Gut microbiome link to Complex Regional Pain Syndrome
Official title: Role of the Gut Microbiome in Complex Regional Pain Syndrome
Run by Washington University School of Medicine · NCT03612193 · Data updated 2026-11-12
This study will test whether differences in the gut microbiome relate to how severe CRPS symptoms are and whether people recover, in adults with CRPS and their household controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | December 19, 2018 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | November 5, 2025 |
| Trial ID | NCT03612193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with CRPS by the Budapest criteria — current or past cases for the cross-sectional arm or diagnoses within 6 months for the longitudinal arm — and willing household cohabitants as controls who speak English and can provide consent and stool samples.
✕Probably not a fit
People who live alone, are pregnant or lactating, follow a vegan diet, do not speak English, or cannot stop probiotic use for one week would be ineligible and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational project has two parts: a cross-sectional arm comparing gut microbiota composition with symptom severity and chronicity in adults with current or past CRPS, and a longitudinal arm following people newly diagnosed (<6 months) to see if microbiome features predict recovery. Stool samples, clinical symptom measures, and tests of cognitive flexibility will be collected, with household cohabitants serving as controls. People who live alone, follow a vegan diet, are pregnant or lactating, or cannot stop probiotics for one week are excluded. All procedures are conducted at Washington University School of Medicine in St. Louis.
Why it matters
Potential benefit: If successful, the findings could help develop microbiome-based markers to predict prognosis and point to new treatment approaches for people with CRPS.
How similar studies have gone: Related research has found preliminary links between the gut microbiome and chronic pain or neuroinflammatory conditions, but longitudinal predictive studies specifically in CRPS are largely novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Lara Crock, MD PhD — Washington University School of Medicine
- Study coordinator: Lara Crock, MD PhD
- Email: crockl@wustl.edu
- Phone: 314-546-3882
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.