NCT03612193 Role of the Gut Microbiome in Complex Regional Pain Syndrome
| NCT ID | NCT03612193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Complex Regional Pain Syndromes |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2018-12-19 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2018-12-19 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Lara Crock, MD PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03612193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Complex Regional Pain Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03612193 currently recruiting?
Yes, NCT03612193 is actively recruiting participants. Contact the research team at crockl@wustl.edu for enrollment information.
Where is the NCT03612193 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT03612193 clinical trial?
NCT03612193 is sponsored by Washington University School of Medicine. The principal investigator is Lara Crock, MD PhD at Washington University School of Medicine. The trial plans to enroll 140 participants.