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NCT06206486 · ClinicalTrials.gov registry record
The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation
A clinical trial of Gut Microbiome and Kidney Transplant Symptoms, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- 133
- Enrollment target
- 1
- Study location
NCT06206486: Recruiting study of Gut Microbiome and Kidney Transplant Symptoms, sponsored by University of Illinois at Chicago.
NCT06206486 is a study of Gut Microbiome and Kidney Transplant Symptoms that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 133 participants, below the 262-participant average among 22 other Gut Microbiome trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06206486, a study of Gut Microbiome and Kidney Transplant Symptoms, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- 133 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Patient Reported Outcomes Measurement System
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 |
What NCT06206486 shows while recruiting
NCT06206486 is an observational study that tracks outcomes without assigning an intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 262-participant average among 22 other Gut Microbiome trials with a reported enrollment target (49% lower).
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.
NCT06206486 reports a single indexed study location in Illinois.
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.
What interventions are being tested in trial NCT06206486?
The interventions under investigation include: no intervention, observational (OTHER).
Who is sponsoring clinical trial NCT06206486?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT06206486's enrollment target sits among peer trials
133 6th of 22 higher than 17 of 22 other Gut Microbiome trials
participants (enrollment target), bucketed by value
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