Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT03612193

Conditions

Complex Regional Pain Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 ID

NCT03612193

Start date

Dec 19, 2018

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

Study A: Chronic >1 year

Study A: Acute <1 year

Study A: Household Control

Study B: Newly Diagnosed <6 months

Study B: Household Controls

Primary outcome measure

  • Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score [ Time Frame: 1 visit - up to one month ]
  • Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Lara Crock, MD PhD

314-546-3882crockl@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Laura Crock, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-11-05.