Gut Microbiome and p-Inulin in Hemodialysis

NCT02572882 | Completed Results DMC

• 2 other identifiers: 823162U01DK099919
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

End-Stage Renal Disease; Gut Microbiome Dysbiosis

Keywords

hemodialysis; p-inulin; gut microbiome

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  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)

  12 weeks

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

  12 weeks

• Number of Participants With Adverse Events (Safety Outcome)

  28 weeks

• Number of Serious Adverse Events (Safety Outcome)

  28 weeks

Study Arms (1)

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).

Dietary Supplement: p-inulin

Interventions

p-inulin DIETARY_SUPPLEMENT

12 week self-administered treatment phase

Single arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Kidney Research Institute, University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 35369018 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Natalie Kuzla
• Organization: University of Pennsylvania

nkuzla@pennmedicine.upenn.edu

215-573-2935

Study Officials

• Laura Dember, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• J Richard Landis, PhD

  Perelman School of Medicine at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: January 24, 2017
• Study Completion: January 1, 2019
• Last Updated: October 20, 2022
• Results First Posted: October 20, 2022

Record last verified: 2022-09

Locations

US (4)