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Trial record 7 of 120 for:    "Complex regional pain syndrome"

Role of the Gut Microbiome in Complex Regional Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03612193
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lara Crock, Washington University School of Medicine

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).

Condition or disease
Complex Regional Pain Syndromes

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of the Gut Microbiome in Complex Regional Pain Syndrome
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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 Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Taxonomic and metabolomic biomarkers


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pain Management Center at Washington University/Barnes-Jewish Hospital medical campus
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612193


Contacts
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Contact: Lara Crock, MD PhD 314-546-3882 crockl@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristi Kraus, RN         
Principal Investigator: Laura Crock, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Lara Crock, MD PhD Washington University School of Medicine

Publications:

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Responsible Party: Lara Crock, Clinical Fellow, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03612193     History of Changes
Other Study ID Numbers: 201806182
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases