End Stage Renal Disease, Gut Microbiome Dysbiosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTP-inulin
Sponsors
Ali Ramezani
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase. | 24 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Within-patient variability in the bacterial composition of the stool during the no treatment phase. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified. |
| Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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 p-inulin treatment phase. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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 | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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 | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. | 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 8 weeks | Assessed by sachet counts |
| Rate of Study Withdrawal | 24 weeks | Number of subjects who withdrew during each phase |
| Number of Participants Who Discontinue Use of p-inulin | 8 week period of treatment | — |
| Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS) | 24 weeks | Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS) |
Countries
United States
Outcome results
None listed