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Chronic Kidney DiseasesTarGutNCT03348592

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

A study testing Oligofructose-enriched inulin (p-inulin) and No treatment in people with Chronic Kidney Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Oligofructose-enriched inulin (p-inulin) and No treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Subjects with eGFR 15.0 to 50.0 ml/min/1.73 m2 as estimated by the CKD-EPI equation
  • Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2
  • Age ≥ 18 years
  • 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
  • Ability to provide informed consent

Who cannot join

  • Use of pre- or pro-biotics during the past 2 months
  • Consumption of probiotic yogurt during the past 2 weeks
  • 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.
  • Presence of HIV infection, chronic wound infection and osteomyelitis
  • Presence of or treatment for periodontal infection
  • Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
Show all 17Show fewer
  • Cirrhosis or chronic active hepatitis
  • 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
  • Treatment with proton pump inhibitors within the last one month
  • Anticipated initiation of dialysis or kidney transplant within 9 months
  • Acute on chronic kidney disease
  • Expected survival < 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.
  • Pregnancy, anticipated pregnancy, or breastfeeding
  • Incarceration
  • Participation in another intervention study
  • Severe anemia defined as hemoglobin <9.0 g/dl any time during the last 3 months
  • Patients in whom frequent blood sampling may be difficult

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Oligofructose-enriched inulin (p-inulin), No treatment
Keywords
Microbiome, p-inulin
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • Oligofructose-enriched inulin (p-inulin)Dietary supplement

  • No treatmentOther

    Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.

Study groups in NCT03348592
Study groupRoleWhat they receive
Oligofructose-enriched inulin (p-inulin)ExperimentalParticipants 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.
Receives: Dietary Supplement: Oligofructose-enriched inulin (p-inulin); Other: No treatment

What is being measured

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

  1. Microbial composition of stool

    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.

    Measured: Stool is collected weekly for 28 weeks

  2. Adherence to p inulin prescription

    Proportion of packets taken vs packets prescribed by packet count

    Measured: Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin

Secondary outcomes (21)

  1. butyrate

    captured by untargeted metabolomics, short chain fatty acid in stool blood and urine

    Measured: Collected weekly for 28 weeks

  2. propionate

    captured by untargeted metabolomics, short chain fatty acid in stool blood and urine

    Measured: Collected weekly for 28 weeks

  3. acetate

    captured by untargeted metabolomics, short chain fatty acid measured in stool blood and urine

    Measured: Collected weekly for 28 weeks

  4. Trimethylamine N oxide

    captured by untargeted metabolomics in stool blood and urine

    Measured: Collected weekly for 28 weeks

  5. Choline

    captured by untargeted metabolomics in stool blood and urine

    Measured: Collected weekly for 28 weeks

  6. Betaine

    captured by untargeted metabolomics in stool blood and urine

    Measured: Collected weekly for 28 weeks

  7. Indoles

    Indoxyl sulfate Indoxyl glucuronide 5-hydroxyindole Indole-3-prioonic acid Indole-3-acetic acid captured by untargeted metabolomics in stool blood and urine

    Measured: collected weekly for 28 weeks

  8. Phenols

    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

    Measured: collected weekly for 28 weeks

  9. polyamines

    captured by untargeted metabolomics in stool blood and urine

    Measured: collected weekly for 28 weeks

  10. metabolites of urea and creatinine metabolism

    captured by untargeted metabolomics in stool blood and urine

    Measured: collected weekly for 28 weeks

  11. Allantoin

    captured by untargeted metabolomics in stool blood and urine

    Measured: collected weekly for 28 weeks

  12. Fructose

    captured by untargeted metabolomics in stool blood and urine

    Measured: collected weekly for 28 weeks

  13. Cytokines

    IL-1β IL-2 IL-4 IL-6 IL-10 IL-17 IL-22 TNFα measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  14. endotoxin

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  15. Myeloperoxdase (MPO)

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  16. hsCRP

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  17. HMGB1

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  18. TNF-R1

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  19. TNF-R2

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  20. Lipopolysaccharide binding protein (LBP)

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

  21. sCD14

    measured by standard ELISA in stool

    Measured: collected weekly for 28 weeks

Timeline

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

  1. First posted21 Nov 2017
  2. Study startOct 2016
  3. Primary completionNov 2017
  4. Study completionJun 2018 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
This is a 28 week study. Participants take no treatment for 8 weeks, followed by 12 weeks on the pre-biotic p-inulin, followed by no treatment for 8 weeks. The treatment arms are no treatment and the pre-biotic p-inulin. Inulin is derived from chicory root fiber.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03348592
Sponsor's protocol ID
DK099877-T
Acronym
TarGut
Status last verified
Nov 2017
First submitted
31 Oct 2017
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Oligofructose-enriched inulin (p-inulin) and No treatment in people with Chronic Kidney Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Nov 2017. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbial composition of stool (time frame: Stool is collected weekly for 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03348592.

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 21 Nov 2017.

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