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

Launched by UNIVERSITY OF TENNESSEE · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how treating constipation can affect patients with chronic kidney disease (CKD). Constipation is a common issue for people with CKD, and researchers want to see if managing this problem can lead to better health outcomes. They will be testing different treatments for constipation to see how they influence patients’ overall health and certain biological markers in the body.

To participate in the study, individuals must be at least 18 years old and diagnosed with CKD stages G3-G5, meaning their kidney function is reduced but they are not on dialysis. They should have constipation that is either due to normal causes or from taking certain pain medications. Participants will need to stop using laxatives for at least a week before joining the trial but can use a specific medication if they have not had a bowel movement for three days. It’s important to note that certain conditions, like a history of specific bowel diseases or recent surgeries, may exclude potential participants from the study. If you join, you can expect to receive treatment for constipation and help researchers understand how it benefits those with CKD.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.