Status:
COMPLETED
Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Florida
Conditions:
Chronic Kidney Disease
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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; howeve...
Eligibility Criteria
Inclusion
- 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
- History of drug abuse, anorexia nervosa, or bulimia.
- History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
- Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
- Galactosemia.
- Allergies to lactulose.
- History of gastrointestinal surgery except appendectomy.
- Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study.
- Use of pre- or probiotics within 30 days prior to enrollment in the study.
- Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding.
- Patients currently participating in another interventional study.
- Major surgery within one month prior to enrollment in the study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
- Patients who the investigator determine have a medical status that would preclude the patient's participation.
- Patients on hemodialysis or peritoneal dialysis.
- Patients with a functional kidney transplant.
- Patients with past lactulose use.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06123195
Start Date
February 1 2024
End Date
November 17 2025
Last Update
December 4 2025
Active Locations (1)
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1
Memphis VA Medical Center
Memphis, Tennessee, United States, 38104