CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Current Bowel Protocol (senna/lactulose) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03148002
NCT03148002Phase 4Completed

An Evaluation of the Efficacy and Safety of a Polyethylene Glycol (PEG) Based Bowel Protocol for the Management of Constipation in Peritoneal Dialysis Patients: A Pilot Study

Nova Scotia Health Authority·interventional·Posted May 10, 2017·Updated Aug 21, 2024

In Brief

A Phase 4 clinical trial evaluating Current Bowel Protocol (senna/lactulose) and PEG Bowel Protocol (PEG/lactulose) for Constipation and Peritoneal Dialysis Complication. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Constipation is a common condition, which occurs one in four Canadians. Maintaining regular bowel movements is imperative because constipation can affect the quality of PD dialysate flow and result in an unwanted effect on the dialysis adequacy. There is limited data on how to best manage constipation in the peritoneal dialysis population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for prevention and treatment of constipation across Canada. Although some PD programs in Canada have already converted to PEG for management of constipation, more research in this population would help guide practice. For now, the current PD bowel regimen at the Nova Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant laxative, senna, along with an osmotic laxative, lactulose, for acute constipation. The investigators will review all patients in the NSHA PD program who have regular or recent laxative use for participation in this study. Patients included in this study will be randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks. The goal is to determine if the PEG Bowel Protocol is as effective and safe for the prevention of constipation as the Current Bowel Protocol used in the PD Program. The investigators will use bowel function diaries and patient surveys to determine efficacy and safety outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartJul 7, 2017
Primary CompletionApr 1, 2018
Study CompletionJun 5, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.1 years ago

Interventions

Current Bowel Protocol (senna/lactulose)drug

Stimulant and Osmotic Laxatives.

PEG Bowel Protocol (PEG/lactulose)drug

Osmotic Laxatives.