Gut Microbiome and p-Inulin in CKD - TarGut CKD Study (TarGut)

November 15, 2017 updated by: Jennifer Gassman, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Gut Microbiome and p-Inulin in CKD TarGut CKD Study

The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in CKD patients. In order to design a future clinical trial the following parameters from CKD subjects are needed:

  1. Intra-patient variability in the composition and function of the gut microbiome
  2. Inter-patient variability in the composition and function of the gut microbiome
  3. Impact of p-inulin on the composition and function of the gut microbiome
  4. Tolerability of p-inulin administration
  5. Feasibility of collecting stool samples in this patient population

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Faculty Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with eGFR 15.0 to 50.0 ml/min/1.73 m2 as estimated by the CKD-EPI equation
  2. Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2
  3. Age ≥ 18 years
  4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. See Section 4.2.1 for definition of childbearing potential and acceptable methods of birth control
  5. Ability to provide informed consent

Exclusion Criteria:

  1. Use of pre- or pro-biotics during the past 2 months
  2. Consumption of probiotic yogurt during the past 2 weeks
  3. Use of antibiotics within the past 3 months if the patient received a single course of antibiotic. If the patient received more than one course of antibiotic treatment, we will wait for 6 months prior to inclusion.
  4. Presence of HIV infection, chronic wound infection and osteomyelitis
  5. Presence of or treatment for periodontal infection
  6. Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
  7. Cirrhosis or chronic active hepatitis
  8. Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone >10 mg in the last 3 months
  9. Treatment with proton pump inhibitors within the last one month
  10. Anticipated initiation of dialysis or kidney transplant within 9 months
  11. Acute on chronic kidney disease
  12. Expected survival < 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.
  13. Pregnancy, anticipated pregnancy, or breastfeeding
  14. Incarceration
  15. Participation in another intervention study
  16. Severe anemia defined as hemoglobin <9.0 g/dl any time during the last 3 months
  17. Patients in whom frequent blood sampling may be difficult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oligofructose-enriched inulin (p-inulin)
Participants are on no treatment for 8 weeks, then the pre-biotic p-inulin for 12 weeks, then no treatment for 8 weeks. Inulin is derived from chicory root fiber. The dose is 16 grams of p-inulin powder per day.
Dietary supplement: Oligofructose-enriched inulin (p-inulin)
Other: No treatment
Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbial composition of stool
Time Frame: Stool is collected weekly for 28 weeks
Microbial taxonomy will be assigned using Ribosomal Database Project (RDP) for 16S, augmented by analysis of specific sequences using BLAST. The 16S tag sequences will be collected into operational taxonomic units (OTUs) with 97% sequence identity.
Stool is collected weekly for 28 weeks
Adherence to p inulin prescription
Time Frame: Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin
Proportion of packets taken vs packets prescribed by packet count
Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
butyrate
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics, short chain fatty acid in stool blood and urine
Collected weekly for 28 weeks
propionate
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics, short chain fatty acid in stool blood and urine
Collected weekly for 28 weeks
acetate
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics, short chain fatty acid measured in stool blood and urine
Collected weekly for 28 weeks
Trimethylamine N oxide
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
Collected weekly for 28 weeks
Choline
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
Collected weekly for 28 weeks
Betaine
Time Frame: Collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
Collected weekly for 28 weeks
Indoles
Time Frame: collected weekly for 28 weeks
Indoxyl sulfate Indoxyl glucuronide 5-hydroxyindole Indole-3-prioonic acid Indole-3-acetic acid captured by untargeted metabolomics in stool blood and urine
collected weekly for 28 weeks
Phenols
Time Frame: collected weekly for 28 weeks

p-cresol sulfate p-Cresol glucuronide Phenyl sulfate Phenyl glucuronide α-N-phenylacetyl-L-glutamine Phenylpropionylglycine Hippuric acid 4-hydroxybenzoate Phenylacetylglycine

* captured by untargeted metabolomics and quantitated by targeted metabolomics in stool blood urine
collected weekly for 28 weeks
polyamines
Time Frame: collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
collected weekly for 28 weeks
metabolites of urea and creatinine metabolism
Time Frame: collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
collected weekly for 28 weeks
Allantoin
Time Frame: collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
collected weekly for 28 weeks
Fructose
Time Frame: collected weekly for 28 weeks
captured by untargeted metabolomics in stool blood and urine
collected weekly for 28 weeks
Cytokines
Time Frame: collected weekly for 28 weeks
IL-1β IL-2 IL-4 IL-6 IL-10 IL-17 IL-22 TNFα measured by standard ELISA in stool
collected weekly for 28 weeks
endotoxin
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
Myeloperoxdase (MPO)
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
hsCRP
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
HMGB1
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
TNF-R1
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
TNF-R2
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
Lipopolysaccharide binding protein (LBP)
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks
sCD14
Time Frame: collected weekly for 28 weeks
measured by standard ELISA in stool
collected weekly for 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
George Washington University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kevin C. Abbott, MD, MPH, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Principal Investigator: Jennifer J. Gassman, Ph.D., The Cleveland Clinic
  • Study Chair: Linda F. Fried, MD, MPH, VA Pittsburgh Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DK099877-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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