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

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).
• 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.