Back to resultsPrebiotics in Peritoneal Dialysis
Primary Purpose
End Stage Renal Disease, Gut Microbiome Dysbiosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P-inulin
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- DaVita Georgetown Home Training Unit
- DaVita K Street
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
No Intervention
Arm Label
Pre-treatment
Intervention
Post-treatment
Arm Description
This arm is the 8-week observation period before the p-inulin treatment phase.
This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).
This arm is the 8-week observation period after the p-inulin treatment phase.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03265639
Brief Title
Prebiotics in Peritoneal Dialysis
Official Title
Prebiotics in Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 21, 2016 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Ramezani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Gut Microbiome Dysbiosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-treatment
Arm Type
No Intervention
Arm Description
This arm is the 8-week observation period before the p-inulin treatment phase.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).
Arm Title
Post-treatment
Arm Type
No Intervention
Arm Description
This arm is the 8-week observation period after the p-inulin treatment phase.
Intervention Type
Dietary Supplement
Intervention Name(s)
P-inulin
Primary Outcome Measure Information:
Title
Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-patient variability in the bacterial composition of the stool during the no treatment phase.
Description
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.
Description
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment
Description
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort variability in the bacterial composition during the no treatment phase.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort variability in the bacterial composition during the p-inulin treatment phase.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Title
Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.
Description
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.
Time Frame
24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Other Pre-specified Outcome Measures:
Title
Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)
Description
Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame
24 weeks
Title
Number of Participants Who Discontinue Use of p-inulin
Time Frame
8 week period of treatment
Title
Number of Participants Who Reduce the Dose of p-inulin
Time Frame
8 week period of treatment
Title
Number of Adverse Events
Time Frame
24 weeks
Title
Enrollment Refusal Rate
Time Frame
2 years
Title
Proportion of completed stool sample collections
Time Frame
24 weeks
Title
Proportion of completed blood sample collections
Time Frame
24 weeks
Title
Adherence rate to p-inulin
Description
Assessed by sachet counts
Time Frame
8 weeks
Title
Rate of Study Withdrawal
Description
Number of subjects who withdrew during each phase
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Raj, MD
Organizational Affiliation
The George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Georgetown Home Training Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
DaVita K Street
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prebiotics in Peritoneal Dialysis
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