Treating constipation in patients with chronic kidney disease

Clinical, Biochemical, and Microbiological Effects of Constipation Treatment in Patients With Chronic Kidney Disease: A Pilot Feasibility Trial

This study is testing a treatment for constipation to see if it helps adults with chronic kidney disease feel better and improve their overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Tennessee (Academic / other)
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT06123195 on ClinicalTrials.gov

What this trial studies

This pilot feasibility trial investigates the effects of constipation treatment on patients with chronic kidney disease (CKD) and constipation. The study aims to assess the feasibility of delivering an intervention focused on alleviating constipation and to evaluate its impact on clinical, biochemical, and microbiological parameters. Participants will include adults with CKD stages G3-G5 who experience functional or opioid-induced constipation. The trial will monitor changes in health outcomes related to both kidney function and gastrointestinal health.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with chronic kidney disease stages G3-G5 and experiencing constipation.

Not a fit: Patients with a history of drug abuse, eating disorders, or other gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve kidney and cardiovascular outcomes for patients suffering from chronic kidney disease and constipation.

How similar studies have performed: While there is limited research specifically on constipation treatment in CKD patients, similar studies have shown potential benefits in related gastrointestinal and kidney health outcomes.

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.

Where this trial is running

Memphis, Tennessee

• Memphis VA Medical Center — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Keiichi Sumida, MD, MPH, PhD

Conditions Chronic Kidney Disease; Constipation; Microbiota