Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial

Eligibility Criteria

• 1. Male or female patients \>18 years old.
• 2. Patients able and willing to provide written informed consent and HIPAA authorization.
• 3. 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.
• 4. Functional or opioid-induced constipation based on the Rome IV criteria.
• 5. 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.
• 6. 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.
• 1. History of drug abuse, anorexia nervosa, or bulimia.
• 2. History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
• 3. Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
• 4. Galactosemia.
• 5. Allergies to lactulose.
• 6. History of gastrointestinal surgery except appendectomy.
• 7. Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study.
• 8. Use of pre- or probiotics within 30 days prior to enrollment in the study.
• 9. Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding.
• 10. Patients currently participating in another interventional study.
• 11. 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.
• 12. Patients who the investigator determine have a medical status that would preclude the patient's participation.
• 13. Patients on hemodialysis or peritoneal dialysis.
• 14. Patients with a functional kidney transplant.
• 15. Patients with past lactulose use.