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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 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.

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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

Interventions

  • OTHER no intervention, observational

Study Locations (1)

Illinois

  • UI Health - Chicago

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2023-10-09
Est. Completion 2028-03

Sponsor

University of Illinois at Chicago

430 total trials

What the Registry Record Tells You About NCT06206486

The ClinicalTrials.gov registry entry for NCT06206486 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 22 other Gut Microbiome trials with a reported enrollment target (49% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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