Role of the Gut Microbiome in Complex Regional Pain Syndrome

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03612193
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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).

Key Dates

Start date
Dec 19, 2018
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
140 participants (estimated)

Arms

  • Arm: Study A: Chronic >1 year
  • Arm: Study A: Acute <1 year
  • Arm: Study A: Household Control
  • Arm: Study B: Newly Diagnosed <6 months
  • Arm: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Laura Crock, MD
Laura Crock, MD (PRINCIPAL_INVESTIGATOR)

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