Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial (NCT06123195) | Clinical Trial Compass
CompletedNot Applicable
Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial
United States14 participantsStarted 2024-02-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patients \>18 years old.
✓. Patients able and willing to provide written informed consent and HIPAA authorization.
✓. CKD stages G3-G5 without kidney replacement therapy with estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 creatinine equation.
✓. Functional or opioid-induced constipation based on the Rome IV criteria.
✓. Patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable.
✓. A negative pregnancy test in female patients prior to enrolment, unless the patient is two years postmenopausal or has had a documented tubal ligation or hysterectomy.
Exclusion criteria
✕. History of drug abuse, anorexia nervosa, or bulimia.
✕. History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
What they're measuring
1
The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol
Timeframe: From enrollment to the end of follow-up at 6 weeks