Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-treatment | No Intervention | This arm is the 8-week observation period before the p-inulin treatment phase. | |
| Intervention | Experimental | This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral). |
|
| Post-treatment | No Intervention | This arm is the 8-week observation period after the p-inulin treatment phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-inulin | Dietary Supplement |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dominic Raj, MD | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Georgetown Home Training Unit | Washington D.C. | District of Columbia | 20007 | United States | ||
| DaVita K Street |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Open label
Not provided
| 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) |
| 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 |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |