Exploring the Gut Microbiome's Role in Pain After Kidney Transplant
The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation (Biome-KT)
This study looks at how the bacteria in the gut might affect chronic pain in people who have had a kidney transplant, and whether diet and stress play a role in this connection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06206486 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiome composition, serum metabolites, and chronic pain in kidney transplant recipients (KTRs). It aims to identify specific microbial phenotypes and their association with pain levels, while also examining how diet and stress may influence these relationships. By integrating longitudinal data, the study seeks to enhance the understanding of host-microbial interactions that contribute to pain in this population. The findings could provide insights into potential biological mechanisms underlying pain after kidney transplantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received a kidney transplant at the University of Illinois Hospital.
Not a fit: Patients who have taken systemic antimicrobials in the past four weeks or have a history of certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for chronic pain in kidney transplant recipients.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between gut microbiota and pain in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receiving a kidney transplant at the University of Illinois Hospital \& Health Sciences System (UI Health) Transplant Center at the University of Illinois Chicago (UIC), * 18 years of age or older (adult), and * Understand the study process and provide written informed consent to participate. Exclusion Criteria: * Having taken systemic antimicrobials (except prophylactic penicillin) in the preceding 4 weeks. * Having received a previous solid organ transplant. * History of colon cancer or of an inflammatory bowel disease. * Planning to receive a multiorgan transplant (e.g., simultaneous pancreas and kidney transplant). * Having a history of Clostridium difficile infection in the preceding 8 weeks.
Where this trial is running
Chicago, Illinois
- UI Health — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Mark Lockwood
- Email: lockmar@uic.edu
- Phone: 314-604-2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.