The Journal of Pediatrics
Volume 153, Issue 2 , Pages 254-261.e1 , August 2008

PEG3350 in the Treatment of Childhood Constipation: A Multicenter, Double-Blinded, Placebo-Controlled Trial

  • Samuel Nurko, MD

      Affiliations

    • Children's Hospital Boston, Boston, MA
    • Corresponding Author InformationReprint requests: Dr Samuel Nurko, Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital, 300 Longwood Avenue, Boston, MA 02115.
    • ,
  • Nader N. Youssef, MD

      Affiliations

    • Goryeb Children's Hospital, Morristown, NJ
    • ,
  • Mahmoud Sabri, MD

      Affiliations

    • Geisinger Medical Center, Danville, PA
    • ,
  • Annette Langseder, RN

      Affiliations

    • Goryeb Children's Hospital, Morristown, NJ
    • ,
  • John McGowan, BS

      Affiliations

    • Braintree Laboratories, Boston, MA
    • ,
  • Mark Cleveland, PhD

      Affiliations

    • Braintree Laboratories, Boston, MA
    • ,
  • Carlo Di Lorenzo, MD

      Affiliations

    • Nationwide Children's Hospital, Columbus, OH.

Received 7 July 2007 ,Revised 5 December 2007 ,Accepted 29 January 2008.

References 

  1. Baker S, Liptak G, Colletti R, Croffie J, Dilorenzo C, Ector W, et al. Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2006;43:e1–e13
  2. Brazzelli M, Griffiths P. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database Syst Rev. 2006;CD002240
  3. Borowitz SM, Cox DJ, Sutphen JL, Kovatchev B. Treatment of childhood encopresis: a randomized trial comparing three treatment protocols. J Pediatr Gastroenterol Nutr. 2002;34:378–384
  4. Nolan T, Debelle G, Oberklaid F, Coffey C. Randomized trial of laxatives in treatment of childhood encopresis. Lancet. 1991;338:523–527
  5. Candy DC, Edwards D, Geraint M. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. J Pediatr Gastroenterol Nutr. 2006;43:65–70
  6. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, et al. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004;53:1590–1594
  7. Berg I, Forsyhte I, Holt P, Watts J. A controlled trial of Senokot in fecal soiling treated by behavioral methods. J Child Psychol Psychiatry. 1983;24:543–549
  8. Baker S, Liptak G, Colletti R, Croffie J, Dilorenzo C, Ector W, et al. Evaluation and treatment of constipation in children: summary of updated recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2006;43:405–407
  9. Schiller LR, Emmett M, Santa Ana CA, Fordtran JS. Osmotic effects of polyethylene glycol. Gastroenterology. 1988;94:933–941
  10. Loening-Baucke V, Pashankar DS. A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence. Pediatrics. 2006;118:528–535
  11. Dupont C, Leluyer B, Amar F, Kalach N, Benhamou PH, Mouterde O, et al. A dose determination study of polyethylene glycol 4000 in constipated children: factors influencing the maintenance dose. J Pediatr Gastroenterol Nutr. 2006;42:178–185
  12. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, et al. Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. J Pediatr Gastroenterol Nutr. 2005;41:625–633
  13. Gremse DA, Hixon J, Crutchfield A. Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Clin Pediatr. 2002;41:225–229
  14. Pashankar DS, Loening-Baucke V, Bishop WP. Safety of polyethylene glycol 3350 for the treatment of chronic constipation in children. Arch Pediatr Adolesc Med. 2003;157:661–664
  15. Pashankar DS, Uc A, Bishop WP. Polyethylene glycol 3350 without electrolytes: a new safe, effective, and palatable bowel preparation for colonoscopy in children. J Pediatr. 2004;144:358–362
  16. Benninga M, Candy DC, Catto-Smith AG, Clayden G, Loening-Baucke V, Di Lorenzo C, et al. The Paris Consensus on Childhood Constipation Terminology (PACCT) Group. J Pediatr Gastroenterol Nutr. 2005;40:273–275
  17. Loening-Baucke V. Polyethylene glycol without electrolytes for children with constipation and encopresis. J Pediatr Gastroenterol Nutr. 2002;34:372–377
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  19. Pashankar DS, Bishop WP. Efficacy and optimal dose of daily polyethylene glycol 3350 for treatment of constipation and encopresis in children. J Pediatr. 2001;139:428–432
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  24. Halpern WI. The treatment of encopretic children. J Am Acad Child Psychiatry. 1977;16:478–499
  25. Cox DJ, Sutphen J, Borowitz S, Kovatchev B, Ling W. Contribution of behavior therapy and biofeedback to laxative therapy in the treatment of pediatric encopresis. Ann Behav Med. 1998;20:70–76

 Supported in part by Braintree Laboratories, Inc, and by grants MO1-RR02172 from NCRR NIH to Children's Hospital Boston GCRC and grant M01 RR 000084 to Children's Hospital of Pittsburgh.

 Conflict of Interest information available at www.jpeds.com.

 The protocol was originally designed by the principal investigator (Dr Nurko), and later modifications occurred with input from Drs DiLorenzo, Youssef, and Sabri. After the protocol was finalized, it was submitted to the sponsor, who agreed to fund the project and participated in some later modifications of the protocol design. The collection of the data was done by the investigators. The analysis of the data was done in a joint fashion between the investigators and the sponsor. The interpretation of the data was done by the investigators. The first draft of the manuscript was written by Dr Nurko, and there was no honorarium involved in the production of the manuscript. Later drafts were modified by the other investigators. The sponsors reviewed the manuscript but did not modify its main content, message, or conclusions. The decision to submit for publication and where to submit were done by the investigators, without any input form the sponsor. The results and publication were not influenced by the sponsor in any way.

PII: S0022-3476(08)00082-6

doi: 10.1016/j.jpeds.2008.01.039

The Journal of Pediatrics
Volume 153, Issue 2 , Pages 254-261.e1 , August 2008

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