End-Stage Renal DiseaseNCT02572882

Gut Microbiome and p-Inulin in Hemodialysis

A study testing p-inulin in people with End-Stage Renal Disease and Gut Microbiome Dysbiosis, run by University of Pennsylvania at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: End-Stage Renal Disease, Gut Microbiome Dysbiosis
What is being tested?: p-inulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 4 sitesUnited States
Study dates: Oct 2015to Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Maintenance hemodialysis therapy for end-stage renal disease
At least 18 years of age
At least 90 days since hemodialysis initiation
Self-reported average stool frequency of at least 1 every other day
For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of p-inulin.
Ability to provide consent

Who cannot join

Use of prebiotics or probiotics during the past 8 weeks
Consumption of probiotic yogurt during the past 2 weeks
Use of antibiotics within the past 8 weeks
Presence of HIV infection, chronic wound infection, osteomyelitis, or current hemodialysis
Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
Cirrhosis or chronic active hepatitis

Show all 12Show fewer

Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
Expected survival less than 9 months
Pregnancy, anticipated pregnancy, or breastfeeding
Incarceration
Participation in another intervention study
Severe anemia defined as hemoglobin <9.0 g/dl within the past 4 weeks as documented in the dialysis unit patient record

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02120
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kidney Research Institute, University of Washington
Seattle, Washington, 98104
The George Washington University
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: A Multi-center Study to Characterize the Gut Microbiome of Individuals With End-stage Renal Disease Treated With Maintenance Hemodialysis, and to Explore Effects of P-inulin on the Gut Microbiome

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

Read the detailed description

This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. The study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. Secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules.

Conditions: End-Stage Renal Disease, Gut Microbiome Dysbiosis
Being tested: p-inulin
Keywords: hemodialysis, p-inulin, gut microbiome
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

p-inulinDietary supplement
12 week self-administered treatment phase

Study groups in NCT02572882
Study group	Role	What they receive
Single arm	Other	This is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment). Receives: Dietary Supplement: p-inulin

What is being measured

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

Within Participant Variability in Microbiome Composition by Treatment Phase
The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition.
Measured: 28 weeks
Within Participant Variability in Stool Metabolome by Treatment Phase
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points.
Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.
Measured: 28 weeks
Within Participant Variability in Plasma Metabolome by Treatment Phase
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points.
Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.
Measured: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment)

Secondary outcomes (10)

Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome)
Gastrointestinal symptoms as measure by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS total score is the sum of 15 0-3 items where 0 indicates absence and 3 an extreme degree of the symptom. A higher score indicates worse outcome. The minimum score is 0, the maximum score is 45.
Measured: GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28.
Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome)
-Early discontinuation of p-inulin
Measured: 12 weeks
Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome)
-Reduction in p-inulin dose
Measured: 12 weeks
Number of Participants With Adverse Events (Safety Outcome)
-Adverse events per participant related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System
Measured: 28 weeks
Number of Serious Adverse Events (Safety Outcome)
Serious adverse events categorized by body systems, related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System
Measured: 28 weeks
Rate of Enrollment Refusal (Feasibility Outcome)
Enrollment refusal rate
Measured: 1 year
Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)
Percent of expected completed protocol-specified stool sample collections
Measured: 28 weeks
Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)
Proportion of completed blood sample collections
Measured: 28 weeks
Adherence Rate of P-inulin Use (Feasibility Outcome)
Proportion of p-inulin packets used
Measured: 12 weeks
Rate of Study Withdrawal (Feasibility Outcome)
Number of withdrawals during each phase of the study
Measured: 28 weeks

Timeline

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

Oct 2015Jan 2019

First posted9 Oct 2015 (estimated)
Study startOct 2015
Primary completion24 Jan 2017
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Not applicable
Intervention model: Sequential
Model description: This is a sequential trial that included three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered. Eleven of the 13 participants in the p-inulin phase entered the post-treatment phase. The other two withdrew prior to the post-treatment phase.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02572882
Sponsor's protocol ID: 823162
Other IDs: U01DK099919
Status last verified: Sep 2022
First submitted: 19 Aug 2015
Last updated: 20 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Raj DS, Sohn MB, Charytan DM, Himmelfarb J, Ikizler TA, Mehrotra R, Ramezani A, Regunathan-Shenk R, Hsu JY, Landis JR, Li H, Kimmel PL, Kliger AS, Dember LM; Hemodialysis Novel Therapies Consortium. The Microbiome and p-Inulin in Hemodialysis: A Feasibility Study. Kidney360. 2021 Jan 15;2(3):445-455. doi: 10.34067/KID.0006132020. eCollection 2021 Mar 25.
PubMed 35369018

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Study to Characterize the Gut Microbiome of Individuals With End-stage Renal Disease Treated With Maintenance Hemodialysis, and to Explore Effects of P-inulin on the Gut Microbiome
ClinicalTrials.gov ID: NCT02572882
Acronym / sponsor ID: 823162
Conditions: End-Stage Renal Disease, Gut Microbiome Dysbiosis
Keywords: hemodialysis, p-inulin, gut microbiome
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brigham and Women's Hospital, George Washington University, Vanderbilt University, University of Washington
Study start: Oct 2015 (actual)
Primary completion: 24 Jan 2017 (actual)
Study completion: Jan 2019 (actual)
First posted: 9 Oct 2015 (estimated)
Results: Posted 20 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: This is a sequential trial that included three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered. Eleven of the 13 participants in the p-inulin phase entered the post-treatment phase. The other two withdrew prior to the post-treatment phase.

Arm	Type	Receives
Single arm	Other	Dietary Supplement: p-inulinThis is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Maintenance hemodialysis therapy for end-stage renal disease
At least 18 years of age
At least 90 days since hemodialysis initiation
Self-reported average stool frequency of at least 1 every other day
For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of p-inulin.

Key exclusion criteria (12 listed)

Use of prebiotics or probiotics during the past 8 weeks
Consumption of probiotic yogurt during the past 2 weeks
Use of antibiotics within the past 8 weeks
Presence of HIV infection, chronic wound infection, osteomyelitis, or current hemodialysis
Inflammatory bowel disease, chronic diarrhea, current C. difficile infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
p-inulin12 week self-administered treatment phase	Dietary supplement	Single arm

Primary outcome

Within Participant Variability in Microbiome Composition by Treatment Phase
Time frame: 28 weeks
The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition.
Within Participant Variability in Stool Metabolome by Treatment Phase
Time frame: 28 weeks
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.
Within Participant Variability in Plasma Metabolome by Treatment Phase
Time frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment)
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.

10 secondary outcomes

Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome)
Time frame: GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28.
Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome)
Time frame: 12 weeks
Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome)
Time frame: 12 weeks
Number of Participants With Adverse Events (Safety Outcome)
Time frame: 28 weeks
Number of Serious Adverse Events (Safety Outcome)
Time frame: 28 weeks
Rate of Enrollment Refusal (Feasibility Outcome)
Time frame: 1 year
Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)
Time frame: 28 weeks
Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)
Time frame: 28 weeks
Adherence Rate of P-inulin Use (Feasibility Outcome)
Time frame: 12 weeks
Rate of Study Withdrawal (Feasibility Outcome)
Time frame: 28 weeks

Results and safety

Results posted to the registry on 20 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Study Cohort	13	11

Primary outcome: Within Participant Variability in Microbiome Composition by Treatment Phase

Time frame: 28 weeks. Median (Inter-Quartile Range). Unit: weighted unifrac distrance

Measure	Full Study Cohort n = 10
pre-treatment	0.165 (0.111 to 0.208)
treatment	0.175 (0.129 to 0.228)
post-treatment	0.210 (0.129 to 0.266)

Population analysed: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

Primary outcome: Within Participant Variability in Stool Metabolome by Treatment Phase

Time frame: 28 weeks. Median (Inter-Quartile Range). Unit: Euclidean distance

Measure	Full Study Cohort n = 10
pre-treatment	14.49 (11.93 to 18.15)
treatment	15.70 (13.37 to 18.32)
post-treatment	16.77 (12.92 to 18.12)

Population analysed: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

Primary outcome: Within Participant Variability in Plasma Metabolome by Treatment Phase

Time frame: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment). Median (Inter-Quartile Range). Unit: Euclidean distance

Measure	Full Study Cohort n = 10
pre-treatment	9.48 (8.04 to 10.59)
treatment	9.47 (8.77 to 10.60)
post-treatment	9.72 (8.76 to 11.09)

Population analysed: Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 weeks from Baseline to End of Study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	2 of 13 (15.4%)	1 of 13 (7.7%)	0 of 13
P-inulin	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Post-treatment	1 of 11 (9.1%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35369018Raj DS, Sohn MB, Charytan DM, Himmelfarb J, Ikizler TA, Mehrotra R, Ramezani A, Regunathan-Shenk R, Hsu JY, Landis JR, Li H, Kimmel PL, Kliger AS, Dember LM; Hemodialysis Novel Therapies Consortium. The Microbiome and p-Inulin in Hemodialysis: A Feasibility Study. Kidney360. 2021 Jan 15;2(3):445-455. doi: 10.34067/KID.0006132020. eCollection 2021 Mar 25.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Dember, MD principal investigator

University of Pennsylvania

J Richard Landis, PhD principal investigator

Perelman School of Medicine at the University of Pennsylvania

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing p-inulin in people with End-Stage Renal Disease and Gut Microbiome Dysbiosis, run by University of Pennsylvania at 4 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Within Participant Variability in Microbiome Composition by Treatment Phase (time frame: 28 weeks). The study lists 3 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 NCT02572882, which also lists 1 linked publication.

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 20 Oct 2022.