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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
DaVita Georgetown Home Training Unit
Washington D.C., District of Columbia, United States
DaVita K Street
Washington D.C., District of Columbia, United States
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.
Time frame: 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)