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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
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.
Memphis VA Medical Center
Memphis, Tennessee, United States
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).
Time frame: From enrollment to the end of follow-up at 6 weeks
Changes in serum creatinine
Changes in serum creatinine from baseline to 2, 4, and 6 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of follow-up at 6 weeks
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