Prebiotics in Peritoneal Dialysis

Study Overview
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Brief Summary
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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.

Official Title
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Prebiotics in Peritoneal Dialysis

Conditions
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End Stage Renal Disease, Gut Microbiome Dysbiosis

Intervention / Treatment
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* Dietary Supplement: P-inulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |