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Recruiting NCT03612193

Role of the Gut Microbiome in Complex Regional Pain Syndrome

— Observational Complex Regional Pain Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Complex Regional Pain Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Score results of the Stroop Color Word Test in relation to CRPS recovery [Time frame: 12 months]
  • 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]
  • Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Publications

  • Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20. PMID 20493633
  • Birklein F, Dimova V. Complex regional pain syndrome-up-to-date. Pain Rep. 2017 Oct 5;2(6):e624. doi: 10.1097/PR9.0000000000000624. eCollection 2017 Nov. PMID 29392238
  • Birklein F, Ajit SK, Goebel A, Perez RSGM, Sommer C. Complex regional pain syndrome - phenotypic characteristics and potential biomarkers. Nat Rev Neurol. 2018 May;14(5):272-284. doi: 10.1038/nrneurol.2018.20. Epub 2018 Mar 16. PMID 29545626
  • Lenz M, Uceyler N, Frettloh J, Hoffken O, Krumova EK, Lissek S, Reinersmann A, Sommer C, Stude P, Waaga-Gasser AM, Tegenthoff M, Maier C. Local cytokine changes in complex regional pain syndrome type I (CRPS I) resolve after 6 months. Pain. 2013 Oct;154(10):2142-2149. doi: 10.1016/j.pain.2013.06.039. Epub 2013 Jun 27. PMID 23811041
  • Ware MA, Bennett GJ. Case report: Long-standing complex regional pain syndrome relieved by a cephalosporin antibiotic. Pain. 2014 Jul;155(7):1412-1415. doi: 10.1016/j.pain.2014.03.014. Epub 2014 Mar 22. PMID 24667741
  • Weinstock LB, Myers TL, Walters AS, Schwartz OA, Younger JW, Chopra PJ, Guarino AH. Identification and Treatment of New Inflammatory Triggers for Complex Regional Pain Syndrome: Small Intestinal Bacterial Overgrowth and Obstructive Sleep Apnea. A A Case Rep. 2016 May 1;6(9):272-6. doi: 10.1213/XAA.0000000000000292. PMID 26867023
  • Fung TC, Olson CA, Hsiao EY. Interactions between the microbiota, immune and nervous systems in health and disease. Nat Neurosci. 2017 Feb;20(2):145-155. doi: 10.1038/nn.4476. Epub 2017 Jan 16. PMID 28092661
  • Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12. PMID 22968153

Identifiers

NCT: NCT03612193 · 201806182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗