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Kidney Transplant SymptomsBIOME-KTNCT06206486

The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation

An observational study of Kidney Transplant Symptoms and Gut Microbiome, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant Symptoms, Gut Microbiome
How many people
133 participants
Where
1 siteUnited States
Study dates
9 Oct 2023to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Kidney Transplant Recipients

Who may be able to join

  • Receiving a kidney transplant at the University of Illinois Hospital \& Health Sciences System (UI Health) Transplant Center at the University of Illinois Chicago (UIC),
  • Planning to receive a kidney transplant at the UI Health Transplant Center
  • 18 years of age or older (adult), and
  • Understand the study process and provide written informed consent to participate.

Who cannot join

  • Having a history of colon cancer or 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mark Lockwood contact

314-604-2050

lockmar@uic.edu

Gullermo Zamora contact

7732208631

gzamor2@uic.edu

United States1 site, 1 recruiting
  • UI Health

    Chicago, Illinois, 60612

    Mark Lockwood, 314-604-2050, lockmar@uic.edu

    Recruiting

Other trials in United States

About this study

Official title: The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation (Biome-KT)

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/functional genes and circulating serum metabolites in KTRs with pain vs no pain, 2) To determine the moderation effects of diet and perceived stress on dynamic temporal relationships between microbiome features, serum metabolites, and pain scores among KTRs, and 3) To use machine learning algorithms to identify host-microbial interactions that are causally linked to pain interference among KTRs. Because kidney function is restored, the kidney transplant model is powerful to study the longitudinal relationships between the microbiome, circulating metabolites and chronic pain in people with ESKD to develop patient-centered interventions to treat pain across the spectrum of CKD.

Read the detailed description

Objectives Aim 1: To determine differential dynamic temporal relationships between microbial composition/ functional genes and circulating serum metabolites in KTRs with pain vs no pain. H1: Specific gut microbiota phenotypes (e.g., low abundance of Akkermansia, differential beta diversity indices) will be identified in those with pain vs no pain, and microbiota taxa will be associated with serum metabolite levels (e.g., decreased SCFAs, serotonin, kynurenic acid, indoles; increased neurotoxic quinolinic acid, endotoxin, urea).

Aim 2: To determine the moderation effects of diet and stress on dynamic temporal relationships between microbiome features, serum metabolites, and pain scores among KTRs. H2: Those with pain will report higher stress and consume a low fiber diet (e.g., fiber grams per 1000 kcal), resulting in a shift to a proinflammation microbiome phenotype (e.g., lower alpha diversity, lower abundances of Akkermansia, higher Enterococcus), lower serum levels of SCFAs, and higher levels of neurotoxic metabolites (e.g., quinolinic acid).

Aim 3 (exploratory): To identify host-microbial interactions that are causally linked to PI among KTRs. H3: Integration of longitudinal data from biomarkers associated with PI into clinical-based dynamic machine learning models (e.g., race, age, income, kidney function, diet, stress) will improve their accuracy by >30% as host and microbial biomarkers can better capture environmental factors associated with PI.

Being tested
no intervention, observational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention, observationalOther

    This study is observational. No intervention description available.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PROMIS

    Patient Reported Outcomes Measurement System

    Measured: baseline, 3 months, 6 months (T scores range form 0-100, higher scores indicate worse level of symptoms).

Secondary outcomes (1)
  1. PSS

    Perceived Stress Scale

    Measured: baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start9 Oct 2023
  3. Primary completionOct 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06206486
Sponsor's protocol ID
2023-0193
Acronym
BIOME-KT
Status last verified
Apr 2026
First submitted
4 Jan 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Symptoms and Gut Microbiome, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mark Lockwood (314-604-2050, lockmar@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS (time frame: baseline, 3 months, 6 months (T scores range form 0-100, higher scores indicate worse level of symptoms).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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