Role of the Gut Microbiome in Complex Regional Pain Syndrome

Complex Regional Pain Syndromes Clinical Trial

Official title:

Role of the Gut Microbiome in Complex Regional Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612193
• Other study ID #: 201806182
• Status: Recruiting
• Start date: December 19, 2018
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: Lara Crock, MD PhD
• Phone: 314-546-3882
• Email: crockl[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (26)

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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. — View Citation

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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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score	Study A	1 visit - up to one month
Primary	Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS	Study B	12 months
Secondary	Score results of the Stroop Color Word Test in relation to CRPS recovery	Study B	12 months
Secondary	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	12 months
Secondary	Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics	Study B	12 months