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PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children

Randomized Study

Jarzebicka, Dorota*; Sieczkowska-Golub, Joanna*; Kierkus, Jaroslaw*; Czubkowski, Piotr*; Kowalczuk-Kryston, Monika; Pelc, Maciej; Lebensztejn, Dariusz; Korczowski, Bartosz; Socha, Piotr*; Oracz, Grzegorz*

Journal of Pediatric Gastroenterology and Nutrition: March 2019 - Volume 68 - Issue 3 - p 318–324
doi: 10.1097/MPG.0000000000002192
Clinical Trials: Gastroenterology
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Objectives: The aim of this study was to compare the clinical efficacy and tolerance of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in infants and children.

Methods: This randomized, multicenter study covered 12 weeks of treatment and 4 weeks of follow-up of patients with functional constipation. Patients were randomized (central randomization) to receive either PEG or lactulose. The primary end points were the number of defecations per week after 12 weeks of treatment and improvement in stool consistency of at least 2 points in the Bristol scale. The secondary end point was the presence of adverse events. Bowel movements ≥3 per week and stool consistency ≥2 (Bristol scale) were considered as successful treatment.

Results: We enrolled 102 patients (M 57, F 45) aged 3.62 ± 1.42 years and 88 completed the study. At week 12, good clinical outcome was achieved in 98% (PEG) and 90% (lactulose). The PEG group had more defecations per week compared with the lactulose group (7.9 ± 0.6 vs 5.7 ± 0.5, P = 0.008) and both groups had similar frequency of defecation with pain (5% vs 5%, P = 0.9), stool retention (7% vs 10%, P = 057), large volume of stools (30% vs 31%, P = 0.9) and hard stools (7% vs 13%, P = 0.58). There were more patients with side effects in the lactulose group (15 vs 23, P = 0.02), mostly bloating and abdominal pain.

Conclusions: PEG 3350 is more effective and causes fewer side effects than lactulose in the treatment of constipation in infants and children.

*Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw

Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok

Paediatric Department, State Hospital, Medical College, University of Rzeszow, Rzeszow, Poland.

Address correspondence and reprint requests to Dorota Jarzebicka, MD, ul. Aleja Dzieci Polskich 20, 04-730 Warsaw (e-mail: dorota.jarzebicka@wp.pl).

Received 22 May, 2018

Accepted 11 October, 2018

PEG 3350 for patients was delivered by Vitis Pharma, Poland.

Clinical Trial Registration: clinicaltrials.gov, NCT03177434

Table of Contents Summary This study compared the clinical efficacy and tolerance of PEG 3350 and lactulose for the treatment of functional constipation in infants and children.

The authors report no conflicts of interest.

© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,