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| Name | Class |
|---|---|
| George Washington University | OTHER |
| University of Pennsylvania | OTHER |
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The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.
The overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in CKD patients. In order to design a future clinical trial the following parameters from CKD subjects are needed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oligofructose-enriched inulin (p-inulin) | Experimental | Participants are on no treatment for 8 weeks, then the pre-biotic p-inulin for 12 weeks, then no treatment for 8 weeks. Inulin is derived from chicory root fiber. The dose is 16 grams of p-inulin powder per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligofructose-enriched inulin (p-inulin) | Dietary Supplement |
| ||
| No treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial composition of stool | Microbial taxonomy will be assigned using Ribosomal Database Project (RDP) for 16S, augmented by analysis of specific sequences using BLAST. The 16S tag sequences will be collected into operational taxonomic units (OTUs) with 97% sequence identity. | Stool is collected weekly for 28 weeks |
| Adherence to p inulin prescription | Proportion of packets taken vs packets prescribed by packet count | Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin |
| Measure | Description | Time Frame |
|---|---|---|
| butyrate | captured by untargeted metabolomics, short chain fatty acid in stool blood and urine | Collected weekly for 28 weeks |
| propionate | captured by untargeted metabolomics, short chain fatty acid in stool blood and urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C. Abbott, MD, MPH | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Jennifer J. Gassman, Ph.D. | The Cleveland Clinic | Principal Investigator |
| Linda F. Fried, MD, MPH | VA Pittsburgh Healthcare System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2022 | |
| Reset | Nov 22, 2022 | |
| Release | Jan 25, 2023 | |
| Reset | Feb 22, 2023 | |
| Release | Mar 17, 2023 | |
| Unrelease | Mar 30, 2023 | |
| Release | Apr 22, 2024 | |
| Reset | May 16, 2024 | |
| Release | Oct 6, 2025 | |
| Reset | Oct 21, 2025 | |
| Release | Nov 18, 2025 | |
| Reset | Dec 9, 2025 | |
| Release | Mar 9, 2026 | |
| Reset | Mar 26, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2016 | Oct 18, 2017 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2022 | Nov 22, 2022 | |||
| Jan 25, 2023 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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This is a 28 week study. Participants take no treatment for 8 weeks, followed by 12 weeks on the pre-biotic p-inulin, followed by no treatment for 8 weeks. The treatment arms are no treatment and the pre-biotic p-inulin. Inulin is derived from chicory root fiber.
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| Other |
Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study. |
|
| Collected weekly for 28 weeks |
| acetate | captured by untargeted metabolomics, short chain fatty acid measured in stool blood and urine | Collected weekly for 28 weeks |
| Trimethylamine N oxide | captured by untargeted metabolomics in stool blood and urine | Collected weekly for 28 weeks |
| Choline | captured by untargeted metabolomics in stool blood and urine | Collected weekly for 28 weeks |
| Betaine | captured by untargeted metabolomics in stool blood and urine | Collected weekly for 28 weeks |
| Indoles | Indoxyl sulfate Indoxyl glucuronide 5-hydroxyindole Indole-3-prioonic acid Indole-3-acetic acid captured by untargeted metabolomics in stool blood and urine | collected weekly for 28 weeks |
| Phenols | p-cresol sulfate p-Cresol glucuronide Phenyl sulfate Phenyl glucuronide α-N-phenylacetyl-L-glutamine Phenylpropionylglycine Hippuric acid 4-hydroxybenzoate Phenylacetylglycine * captured by untargeted metabolomics and quantitated by targeted metabolomics in stool blood urine | collected weekly for 28 weeks |
| polyamines | captured by untargeted metabolomics in stool blood and urine | collected weekly for 28 weeks |
| metabolites of urea and creatinine metabolism | captured by untargeted metabolomics in stool blood and urine | collected weekly for 28 weeks |
| Allantoin | captured by untargeted metabolomics in stool blood and urine | collected weekly for 28 weeks |
| Fructose | captured by untargeted metabolomics in stool blood and urine | collected weekly for 28 weeks |
| Cytokines | IL-1β IL-2 IL-4 IL-6 IL-10 IL-17 IL-22 TNFα measured by standard ELISA in stool | collected weekly for 28 weeks |
| endotoxin | measured by standard ELISA in stool | collected weekly for 28 weeks |
| Myeloperoxdase (MPO) | measured by standard ELISA in stool | collected weekly for 28 weeks |
| hsCRP | measured by standard ELISA in stool | collected weekly for 28 weeks |
| HMGB1 | measured by standard ELISA in stool | collected weekly for 28 weeks |
| TNF-R1 | measured by standard ELISA in stool | collected weekly for 28 weeks |
| TNF-R2 | measured by standard ELISA in stool | collected weekly for 28 weeks |
| Lipopolysaccharide binding protein (LBP) | measured by standard ELISA in stool | collected weekly for 28 weeks |
| sCD14 | measured by standard ELISA in stool | collected weekly for 28 weeks |
| Feb 22, 2023 |
| Mar 17, 2023 | Mar 30, 2023 |
| Apr 22, 2024 | May 16, 2024 |
| Oct 6, 2025 | Oct 21, 2025 |
| Nov 18, 2025 | Dec 9, 2025 |
| Mar 9, 2026 | Mar 26, 2026 |
| Jul 8, 2026 |
| 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 |