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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK135942 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Florida | OTHER |
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Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Constipation treatment | Experimental | A 4-week intervention of constipation treatment with lactulose |
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| Control | No Intervention | No constipation treatment except bisacodyl rescue therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constipation treatment | Other | Lactulose 15 mL (10 g) will be taken orally once daily (in the evening), which can be titrated at 1-week intervals in 15 mL (10 g) increments or decrements up to 60 mL (40 g) as a total daily dose. |
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol | The feasibility of delivering the applied interventions and performing the proposed examinations will be determined based on the following feasibility outcomes, assessed as 1) ≥90% of participants randomized in the intervention group and under observation will adhere to the proposed intervention, 2) ≥80% patients under observation will adhere to the study-specific timed collection of stool, urine, and blood samples, and 3) ≥85% patients will complete the study (<15% patients will be dropped out). | From enrollment to the end of follow-up at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum creatinine | Changes in serum creatinine from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in serum phosphorus | Changes in serum phosphorus from baseline to 2, 4, and 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memphis VA Medical Center | Memphis | Tennessee | 38104 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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A single-center, open-label, randomized, controlled, parallel-group, pilot feasibility trial
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| From enrollment to the end of follow-up at 6 weeks |
| Changes in serum p-cresyl sulfate and indoxyl sulfate | Changes in serum p-cresyl sulfate and indoxyl sulfate from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in plasma potassium | Changes in plasma potassium from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in plasma C-reactive protein | Changes in plasma C-reactive protein from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in plasma lipopolysaccharide | Changes in plasma lipopolysaccharide from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR) | Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR) from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in microbial parameters | Changes in gut and circulating microbiota from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in stool consistency | Changes in stool consistency assessed by Bristol Stool Form Scale (BSFS) from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| Changes in constipation symptoms | Changes in constipation symptoms assessed by Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 2, 4, and 6 weeks. | From enrollment to the end of follow-up at 6 weeks |
| 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 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |