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Complex Regional Pain SyndromesNCT03612193

Role of the Gut Microbiome in Complex Regional Pain Syndrome

An observational study of Complex Regional Pain Syndromes, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Complex Regional Pain Syndromes
How many people
140 participants
Where
1 siteUnited States
Study dates
19 Dec 2018to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Pain Management Center at Washington University/Barnes-Jewish Hospital medical campus

Who may be able to join

  • 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
  • Adults over age of 18
  • Cohabitant of person with current or former diagnosis of CRPS
Show all 19Show fewer
  • Study B: Longitudinal Study
  • 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
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lara Crock, MD PhD contact

314-546-3882

crockl@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Laura Crock, MD

    Laura Crock, MD

    Recruiting

Other trials in United States

About this study

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).

Medical subject headings
Complex Regional Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03612193
Study groupRoleWhat they receive
Study A: Chronic >1 yearNot described
Study A: Acute <1 yearNot described
Study A: Household ControlNot described
Study B: Newly Diagnosed <6 monthsNot described
Study B: Household ControlsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score

    Study A

    Measured: 1 visit - up to one month

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

    Study B

    Measured: 12 months

Secondary outcomes (3)

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

    Study B

    Measured: 12 months

  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)

    Study B

    Measured: 12 months

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

    Study B

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start19 Dec 2018
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612193
Sponsor's protocol ID
201806182
Status last verified
Nov 2025
First submitted
9 Jul 2018
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22968153

  • Frank DN, Robertson CE, Hamm CM, Kpadeh Z, Zhang T, Chen H, Zhu W, Sartor RB, Boedeker EC, Harpaz N, Pace NR, Li E. Disease phenotype and genotype are associated with shifts in intestinal-associated microbiota in inflammatory bowel diseases. Inflamm Bowel Dis. 2011 Jan;17(1):179-84. doi: 10.1002/ibd.21339. Epub 2010 Sep 13.

    PubMed 20839241

  • Bercik P, Denou E, Collins J, Jackson W, Lu J, Jury J, Deng Y, Blennerhassett P, Macri J, McCoy KD, Verdu EF, Collins SM. The intestinal microbiota affect central levels of brain-derived neurotropic factor and behavior in mice. Gastroenterology. 2011 Aug;141(2):599-609, 609.e1-3. doi: 10.1053/j.gastro.2011.04.052. Epub 2011 Apr 30.

    PubMed 21683077

  • Shen S, Lim G, You Z, Ding W, Huang P, Ran C, Doheny J, Caravan P, Tate S, Hu K, Kim H, McCabe M, Huang B, Xie Z, Kwon D, Chen L, Mao J. Gut microbiota is critical for the induction of chemotherapy-induced pain. Nat Neurosci. 2017 Sep;20(9):1213-1216. doi: 10.1038/nn.4606. Epub 2017 Jul 17.

    PubMed 28714953

  • Amaral FA, Sachs D, Costa VV, Fagundes CT, Cisalpino D, Cunha TM, Ferreira SH, Cunha FQ, Silva TA, Nicoli JR, Vieira LQ, Souza DG, Teixeira MM. Commensal microbiota is fundamental for the development of inflammatory pain. Proc Natl Acad Sci U S A. 2008 Feb 12;105(6):2193-7. doi: 10.1073/pnas.0711891105. Epub 2008 Feb 11.

    PubMed 18268332

  • Nayak RR, Turnbaugh PJ. Mirror, mirror on the wall: which microbiomes will help heal them all? BMC Med. 2016 May 4;14:72. doi: 10.1186/s12916-016-0622-6.

    PubMed 27146150

  • Wang F, Meng J, Zhang L, Johnson T, Chen C, Roy S. Morphine induces changes in the gut microbiome and metabolome in a morphine dependence model. Sci Rep. 2018 Feb 26;8(1):3596. doi: 10.1038/s41598-018-21915-8.

    PubMed 29483538

  • Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.

    PubMed 19837031

Questions about this trial

What is this clinical trial studying?

An observational study of Complex Regional Pain Syndromes, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lara Crock, MD PhD (314-546-3882, crockl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03612193, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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