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The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation
NCT06206486 · View on ClinicalTrials.gov ↗
Study Summary
Study Summary Nearly half (47%) of people with end-stage kidney disease (ESKD) whose kidney function is restored after kidney transplantation experience chronic pain compared to 19% of adults in the US general population. Pain is associated with comorbid fatigue, depression and anxiety, and withdrawal from usual physical and social activities; resulting in an inability to participate in and enjoy life. Severe pain can result in nonadherence to immunosuppression and treatment protocols and result in an increased risk of rejection, graft loss, and mortality. The role of symbiotic microbes (microbiota) in the gastrointestinal tract, and their functional genes (microbiome), is well established in diseases involving pain. Diet and stress play a major role in synthesis of signaling molecules critical to immunologic, metabolic, and endocrine pathways regulating chronic pain. Dietary patterns change dramatically after transplantation, as recipients move from a restricted "renal" diet to a regular diet, often resulting in increased consumption of foods high in sugars and fat. Moreover, psychological stress significantly impairs the function of the microbiome, initiating biological pathways involved in pain, leading to a disproportionate pain burden. Because the microbiome, serum metabolites, and pain are dynamic, our novel investigation will employ a prospective repeated measures design to interrogate the dynamic temporal relationships between the microbiome, metabolites associated with pathways regulating pain, transplantation factors (e.g. immunosuppression, kidney function), changing dietary patterns, and perceived stress, on pain scores before and after kidney transplantation. The investigators posit the gut microbiome, and its byproducts, may partially explain the underlying biological mechanisms of pain Interference in kidney disease. The investigators will address three aims: 1) To determine differential dynamic temporal relationships between microbial composition/fun
Conditions Studied
Interventions
- OTHER no intervention, observational
Study Locations (1)
Illinois
- UI Health — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2028-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06206486
The ClinicalTrials.gov registry entry for NCT06206486 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 421 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Gut Microbiome appearing as the primary indexed condition, and to 1 intervention — of which no intervention, observational is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06206486 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06206486 about?
NCT06206486 is a clinical study titled "The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation". Study Summary Nearly half (47%) of people with end-stage kidney disease (ESKD) whose kidney function is restored after kidney transplantation experience chronic pain compared to 19% of adults in the US general population. Pain is associated with comorbid fatigue, depression and anxiety, and withdraw...
What is the current status of trial NCT06206486?
This trial is currently recruiting. The enrollment target is 133 participants. The study started on 2023-10-09. Estimated completion is 2028-03.
What conditions does trial NCT06206486 study?
This clinical trial studies the following conditions: Gut Microbiome, Kidney Transplant Symptoms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06206486?
The interventions under investigation include: no intervention, observational (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06206486?
This trial is sponsored by University of Illinois at Chicago, which has 421 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06206486 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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