← Back to Search

Osmotic Laxative

Current Bowel Protocol for Peritoneal Dialysis

Phase 4
Waitlist Available
Led By Jaclyn Y Tran, BScPharm
Research Sponsored by Jaclyn Tran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Peritoneal Dialysis
  • Constipation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of constipation treatment success
Secondary outcome measures
Incidence of peritoneal dialysis treatment failure requiring intervention
Mean change from baseline on the PAC-QOL questionnaire
Mean change from baseline on the PAC-SYM questionnaire
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Current Bowel ProtocolActive Control1 Intervention
Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy.
Group II: PEG Bowel ProtocolActive Control1 Intervention
Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy.

Find a Location

Who is running the clinical trial?

Jaclyn TranLead Sponsor
Jaclyn Y Tran, BScPharmPrincipal InvestigatorNova Scotia Health Authority

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~4 spots leftby May 2025