Prebiotics in Peritoneal Dialysis

The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Gut Microbiome Dysbiosis
• Intervention / Treatment: Dietary supplement: P-inulin

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • DaVita Georgetown Home Training Unit
    • Washington, District of Columbia, United States, 20037
      • DaVita K Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Peritoneal dialysis therapy for end-stage renal disease
• ≥30 days since dialysis initiation
• Ability to provide informed consent

Exclusion Criteria:

• Use of pre- or pro-biotics during the past 2 months
• Consumption of pro-biotic yogurt during the past 2 weeks
• Use of antibiotics within the past 2 months
• Presence of chronic infection
• Chronic gastrointestinal condition other than constipation
• Cirrhosis or chronic active hepatitis
• Stomach/intestinal resection
• PD access problems
• Anticipated kidney transplant or transfer to another dialysis unit within 9 months
• Expected survival < 9 months
• Pregnancy, anticipated pregnancy, or breastfeeding
• Incarceration
• Participation in another intervention study
• Severe anemia defined as hemoglobin <9.0 g/dl

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-treatment; This arm is the 8-week observation period before the p-inulin treatment phase.
Experimental: Intervention; This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).	Dietary supplement: P-inulin
No Intervention: Post-treatment; This arm is the 8-week observation period after the p-inulin treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient variability in the bacterial composition of the stool during the no treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the bacterial composition during the no treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the bacterial composition during the p-inulin treatment phase.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment	Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.	Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.	24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)	24 weeks
Number of Participants Who Discontinue Use of p-inulin		8 week period of treatment
Number of Participants Who Reduce the Dose of p-inulin		8 week period of treatment
Number of Adverse Events		24 weeks
Enrollment Refusal Rate		2 years
Proportion of completed stool sample collections		24 weeks
Proportion of completed blood sample collections		24 weeks
Adherence rate to p-inulin	Assessed by sachet counts	8 weeks
Rate of Study Withdrawal	Number of subjects who withdrew during each phase	24 weeks

Collaborators and Investigators

• Sponsor: Ali Ramezani
• Investigators: Principal Investigator: Dominic Raj, MD, The George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2016
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Dysbiosis
• Other Study ID Numbers: 091440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No