Role of the Gut Microbiome in Complex Regional Pain Syndrome

NCT ID: NCT03612193

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2027-07-31

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).

Conditions

Complex Regional Pain Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study A: Chronic >1 year

No interventions assigned to this group

Study A: Acute <1 year

No interventions assigned to this group

Study A: Household Control

No interventions assigned to this group

Study B: Newly Diagnosed <6 months

No interventions assigned to this group

Study B: Household Controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Adults over age of 18
• Cohabitant of person with current or former diagnosis of CRPS

Study B: Longitudinal Study

• 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

• Adults over age of 18
• Cohabitant of person with diagnosis of CRPS

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lara Crock, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lara Crock, MD PhD

Role: CONTACT

crockl@wustl.edu

314-546-3882

Facility Contacts

Laura Crock, MD

Role: primary

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Other Identifiers

201806182

Identifier Type: -

Identifier Source: org_study_id