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

NCT06123195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

OTHER

Constipation treatment

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Florida

    collaborator OTHER

  • University of Tennessee

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-11-17
Completion
2025-11-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123195 on ClinicalTrials.gov