Peritoneal Dialysis Pilot Study: Evaluating Polyethylene Glycol (PEG) for Constipation

July 18, 2017 updated by: Jaclyn Tran

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Constipation is a common condition, which impacts one in four Canadians Maintaining regular bowel movements is important in the peritoneal dialysis (PD) population because constipation can negatively impact the quality of dialysate flow and can result in impaired dialysis adequacy. Unfortunately, treating constipation is challenging in PD patients because of the diet and fluid restrictions required in this population, as well as the need for constipating calcium based phosphate binders.

Constipation treatment can be administered orally or rectally. Although patients often prefer oral therapy, there are occasions when rectal therapy is preferred (ie. rectal suppositories and enemas). Oral laxatives include bulk, osmotic, stimulant, and lubricants.

In the Nova Scotia (NS) PD Program, patients are counseled to maintain a type 3-4 stool on the Bristol Stool Chart (BSC). An ideal stool is a type 4, which appears like a sausage or snake and is smooth and soft in consistency. To maintain a type 3-4 stool, current therapy includes senna 8.6-17.2 g twice daily with the addition of lactulose 30-60 mL twice daily, as needed. Rescue therapy in the Current Bowel Protocol is lactulose 30-60 mL every hour until bowel movement.

There is limited evidence to guide the ideal bowel regimen in PD patients. Reasons to consider PEG therapy include the evidence promoting PEG in the general population with constipation, the positive outcomes found in a small population of PD patients (Mimidis 2005), as well as positive feedback from other provinces who currently recommend PEG in PD patients. The investigators postulate the PEG protocol would be as effective and safe as the Current Bowel Protocol, and thus will evaluate PEG in the PD population, the investigators will conduct a prospective, interventional, randomized, open label, pilot study.

All patients with recent laxative use will be approached for inclusion. Patients will be randomly assigned to the Current Bowel Protocol (senna/lactulose) or the PEG Bowel Protocol (PEG/lactulose) for 8 weeks.

The primary objective is to compare the efficacy of the PEG Bowel Protocol in preventing constipation to the Current Bowel Protocol. We will review the safety of the regimens by monitoring for adverse events from all laxatives and explore the impact of constipation in patients who experience PD treatment failure.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jo-Anne Wilson, PharmD

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives.

Exclusion Criteria:

  • Allergy or intolerance to any of the study laxatives (PEG, senna, lactulose); cognitive impairment or inability to document symptoms; known or suspected gastrointestinal obstruction or ileus; known or planned pregnancy; no laxative use in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Current Bowel Protocol
Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy.
Drug: Current Bowel Protocol (senna/lactulose)
Stimulant and Osmotic Laxatives.
Other Names:
  • Lactulose
  • Senna
  • Sennosides
  • DIN 02242814
  • DIN: 02412268
  • NPN: 00367729
  • NPN: 00026158
Active Comparator: PEG Bowel Protocol
Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy.
Drug: PEG Bowel Protocol (PEG/lactulose)
Osmotic Laxatives.
Other Names:
  • PEG
  • Lactulose
  • DIN 02242814
  • DIN: 02412268
  • Lax-A-Day
  • Pegalax
  • DIN: 02328232
  • Restoralax
  • DIN: 02318164
  • DIN: 02317680

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of constipation treatment success
Time Frame: 8 weeks.
Successful treatment of constipation will be defined based on a modified ROME criteria developed by Dipalma 2007: relief of constipation for more than 50% of the weeks in the study.
8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with laxative related adverse effects.
Time Frame: 8 weeks.
Compare the occurrence of side effects during the study period.
8 weeks.
Mean change from baseline on the PAC-SYM questionnaire
Time Frame: 8 weeks.
Measure of the impact of constipation disease severity. PAC-SYM = Patient Assessment of Constipation Symptoms (Frank 1999 and Bove 2012)
8 weeks.
Mean change from baseline on the PAC-QOL questionnaire
Time Frame: 8 weeks
Measure the impact of constipation on quality of life. PAC-QOL = Patient Assessment of Constipation Quality of Life (Marquis 2005 and Bove 2012)
8 weeks
Incidence of peritoneal dialysis treatment failure requiring intervention
Time Frame: 8 weeks
Interventions include antibiotics for peritonitis, catheter re-positioning.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaclyn Tran

Investigators

  • Principal Investigator: Jaclyn Y Tran, BScPharm, Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDBowel2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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