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NCT Number: NCT03612193

Role of the Gut Microbiome in Complex Regional Pain Syndrome

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).

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Laura Crock, MD

CONTACT

Laura Crock, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Study A

  2. Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS

    Time frame: 12 months

    Study B

Secondary outcomes

  1. Score results of the Stroop Color Word Test in relation to CRPS recovery

    Time frame: 12 months

    Study B

  2. Logistic regression analysis for testing the association of CRPS severity score to weight in kilograms and height in meters aggregated to BMI (kilograms/meters squared)

    Time frame: 12 months

    Study B

  3. Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics

    Time frame: 12 months

    Study B

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Crock, MD PhD

CONTACT

[email protected]

314-546-3882

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2018
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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