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Completed

NCT Number: NCT02572882

Gut Microbiome and p-Inulin in Hemodialysis

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gut Microbiome Dysbiosis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

p-inulin

Dietary Supplement

12 week self-administered treatment phase

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

    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.

  2. Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome)

    Time frame: 12 weeks

    -Early discontinuation of p-inulin

  3. Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome)

    Time frame: 12 weeks

    -Reduction in p-inulin dose

  4. Number of Participants With Adverse Events (Safety Outcome)

    Time frame: 28 weeks

    -Adverse events per participant related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System

  5. Number of Serious Adverse Events (Safety Outcome)

    Time frame: 28 weeks

    Serious adverse events categorized by body systems, related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System

  6. Rate of Enrollment Refusal (Feasibility Outcome)

    Time frame: 1 year

    Enrollment refusal rate

  7. Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)

    Time frame: 28 weeks

    Percent of expected completed protocol-specified stool sample collections

  8. Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)

    Time frame: 28 weeks

    Proportion of completed blood sample collections

  9. Adherence Rate of P-inulin Use (Feasibility Outcome)

    Time frame: 12 weeks

    Proportion of p-inulin packets used

  10. Rate of Study Withdrawal (Feasibility Outcome)

    Time frame: 28 weeks

    Number of withdrawals during each phase of the study

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Brigham and Women's Hospital
  • George Washington University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Washington
  • Vanderbilt University

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Oct 9, 2015
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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