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

NCT03148002 | Completed Phase 4

• 1 other identifier: PDBowel2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Peritoneal Dialysis Complication

Outcome Measures

Primary Outcomes (1)

• Rate of constipation treatment success

  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 Outcomes (4)

• Number of patients with laxative related adverse effects.

  8 weeks.

• Mean change from baseline on the PAC-SYM questionnaire

  8 weeks.

• Mean change from baseline on the PAC-QOL questionnaire

  8 weeks

• Incidence of peritoneal dialysis treatment failure requiring intervention

  8 weeks

Study Arms (2)

Current Bowel Protocol

ACTIVE COMPARATOR

Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy.

Drug: Current Bowel Protocol (senna/lactulose)

PEG Bowel Protocol

ACTIVE COMPARATOR

Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy.

Drug: PEG Bowel Protocol (PEG/lactulose)

Interventions

Current Bowel Protocol (senna/lactulose) DRUG

Stimulant and Osmotic Laxatives.

Also known as: Senna, Lactulose, Sennosides, DIN 02242814, DIN: 02412268, NPN: 00367729, NPN: 00026158

Current Bowel Protocol

PEG Bowel Protocol (PEG/lactulose) DRUG

Osmotic Laxatives.

Also known as: PEG, Lax-A-Day, Pegalax, DIN: 02328232, Restoralax, DIN: 02318164, DIN: 02317680, Lactulose, DIN 02242814, DIN: 02412268

PEG Bowel Protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (23)

• Mimidis K, Mourvati E, Kaliontzidou M, Papadopoulos V, Thodis E, Kartalis G, Vargemezis V. Efficacy of polyethylene glycol in constipated CAPD patients. Perit Dial Int. 2005 Nov-Dec;25(6):601-3. No abstract available.

  PMID: 16411529 BACKGROUND

• Setyapranata S, Holt SG. The Gut in Older Patients on Peritoneal Dialysis. Perit Dial Int. 2015 Nov;35(6):650-4. doi: 10.3747/pdi.2014.00341.

  PMID: 26702007 BACKGROUND

• Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol. 2001 Nov;96(11):3130-7. doi: 10.1111/j.1572-0241.2001.05259.x.

  PMID: 11721760 BACKGROUND

• Sutton D, Dumbleton S, Allaway C. Can increased dietary fibre reduce laxative requirement in peritoneal dialysis patients? J Ren Care. 2007 Oct-Dec;33(4):174-8. doi: 10.1111/j.1755-6686.2007.tb00068.x.

  PMID: 18298035 BACKGROUND

• Sutton D, Ovington S, Engel B. A multi-centre, randomised trial to assess whether increased dietary fibre intake (using a fibre supplement or high-fibre foods) produces healthy bowel performance and reduces laxative requirement in free living patients on peritoneal dialysis. J Ren Care. 2014 Sep;40(3):157-63. doi: 10.1111/jorc.12056. Epub 2014 Mar 20.

  PMID: 24650128 BACKGROUND

• Dessau RB, Olsen OB, Frifelt JJ, Skott H. Influence of psyllium seed husk on azotemia, electrolytes, and bowel regulation in patients on CAPD. Perit Dial Int. 1989;9(4):351. No abstract available.

  PMID: 2488394 BACKGROUND

• Pare P. The approach to diagnosis and treatment of chronic constipation: suggestions for a general practitioner. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):36B-40B. doi: 10.1155/2011/368189.

  PMID: 22114756 BACKGROUND

• Liu LW. Chronic constipation: current treatment options. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):22B-28B.

  PMID: 22114754 BACKGROUND

• Schuster BG, Kosar L, Kamrul R. Constipation in older adults: stepwise approach to keep things moving. Can Fam Physician. 2015 Feb;61(2):152-8. No abstract available.

  PMID: 25676646 BACKGROUND

• Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005 Apr;100(4):936-71. doi: 10.1111/j.1572-0241.2005.40925.x.

  PMID: 15784043 BACKGROUND

• Hsieh C. Treatment of constipation in older adults. Am Fam Physician. 2005 Dec 1;72(11):2277-84.

  PMID: 16342852 BACKGROUND

• Di Palma JA, Smith JR, Cleveland Mv. Overnight efficacy of polyethylene glycol laxative. Am J Gastroenterol. 2002 Jul;97(7):1776-9. doi: 10.1111/j.1572-0241.2002.05840.x.

  PMID: 12135034 BACKGROUND

• Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.

  PMID: 9895382 BACKGROUND

• Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007570. doi: 10.1002/14651858.CD007570.pub2.

  PMID: 20614462 BACKGROUND

• Christie AH, Culbert P, Guest JF. Economic impact of low dose polyethylene glycol 3350 plus electrolytes compared with lactulose in the management of idiopathic constipation in the UK. Pharmacoeconomics. 2002;20(1):49-60. doi: 10.2165/00019053-200220010-00005.

  PMID: 11817992 BACKGROUND

• Taylor RR, Guest JF. The cost-effectiveness of macrogol 3350 compared to lactulose in the treatment of adults suffering from chronic constipation in the UK. Aliment Pharmacol Ther. 2010 Jan 15;31(2):302-12. doi: 10.1111/j.1365-2036.2009.04191.x. Epub 2009 Nov 3.

  PMID: 19886948 BACKGROUND

• Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.

  PMID: 16678561 BACKGROUND

• Bove A, Pucciani F, Bellini M, Battaglia E, Bocchini R, Altomare DF, Dodi G, Sciaudone G, Falletto E, Piloni V, Gambaccini D, Bove V. Consensus statement AIGO/SICCR: diagnosis and treatment of chronic constipation and obstructed defecation (part I: diagnosis). World J Gastroenterol. 2012 Apr 14;18(14):1555-64. doi: 10.3748/wjg.v18.i14.1555.

  PMID: 22529683 BACKGROUND

• Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. Am J Gastroenterol. 2015 May;110(5):741-8. doi: 10.1038/ajg.2015.115. Epub 2015 Apr 14.

  PMID: 25869393 BACKGROUND

• Dipalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007 Jul;102(7):1436-41. doi: 10.1111/j.1572-0241.2007.01199.x. Epub 2007 Mar 31.

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  PMID: 10522604 BACKGROUND

• Gokal R, Alexander S, Ash S, Chen TW, Danielson A, Holmes C, Joffe P, Moncrief J, Nichols K, Piraino B, Prowant B, Slingeneyer A, Stegmayr B, Twardowski Z, Vas S. Peritoneal catheters and exit-site practices toward optimum peritoneal access: 1998 update. (Official report from the International Society for Peritoneal Dialysis). Perit Dial Int. 1998 Jan-Feb;18(1):11-33. No abstract available.

  PMID: 9527026 BACKGROUND

Related Links

• Drug monographs for senna, lactulose, and polyethylene glycol

MeSH Terms

Conditions

Constipation

Interventions

Sennosides; Lactulose; Phenolphthalein

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Disaccharides; Oligosaccharides; Polysaccharides; Sugars; Phenolphthaleins; Phenols; Benzene Derivatives

Study Officials

• Jaclyn Y Tran, BScPharm

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to received the Current Bowel Protocol or the PEG Bowel Protocol

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: May 10, 2017
• Study Start: July 7, 2017
• Primary Completion: April 1, 2018
• Study Completion: June 5, 2018
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)