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

NCT06123195 | Completed

• 2 other identifiers: 23-09272-XPR01DK135942
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.

Conditions

Chronic Kidney Disease; Constipation

Keywords

Chronic Kidney Disease; Constipation; Microbiota

Outcome Measures

Primary Outcomes (1)

• The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol

  The feasibility of delivering the applied interventions and performing the proposed examinations will be determined based on the following feasibility outcomes, assessed as 1) ≥90% of participants randomized in the intervention group and under observation will adhere to the proposed intervention, 2) ≥80% patients under observation will adhere to the study-specific timed collection of stool, urine, and blood samples, and 3) ≥85% patients will complete the study (\<15% patients will be dropped out).

  From enrollment to the end of follow-up at 6 weeks

Secondary Outcomes (10)

• Changes in serum creatinine

  From enrollment to the end of follow-up at 6 weeks

• Changes in serum phosphorus

  From enrollment to the end of follow-up at 6 weeks

• Changes in serum p-cresyl sulfate and indoxyl sulfate

  From enrollment to the end of follow-up at 6 weeks

• Changes in plasma potassium

  From enrollment to the end of follow-up at 6 weeks

• Changes in plasma C-reactive protein

  From enrollment to the end of follow-up at 6 weeks

Study Arms (2)

Constipation treatment

EXPERIMENTAL

A 4-week intervention of constipation treatment with lactulose

Other: Constipation treatment

Control

NO INTERVENTION

No constipation treatment except bisacodyl rescue therapy

Interventions

Constipation treatment OTHER

Lactulose 15 mL (10 g) will be taken orally once daily (in the evening), which can be titrated at 1-week intervals in 15 mL (10 g) increments or decrements up to 60 mL (40 g) as a total daily dose.

Constipation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead
• University of Florida: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Constipation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, open-label, randomized, controlled, parallel-group, pilot feasibility trial

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 8, 2023
• Study Start: February 1, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)