Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

Summary

Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. The basis of assessment is to compare the number of commissioned stools (more than three stools per week) and stool consistency according to the scale of Bristol, in children taking Dicopeg Junior and children treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one of two groups, in which the treatment will be as follows for 12 weeks: 1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of: * weight up to 8 kg - 1 sachet per day * weight 8 - 12 kg - 2 sachets a day * weight 12 - 20 kg - 3 sachets a day * weight\> 20 kg - 4 sachets per day, 2. The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg Junior and Lactulose will be administered orally for the duration of the study (12 weeks).

Timeline

Start

2016-02

Primary completion

2018-05

Completion

2018-05

Publications

• Background Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.
• Background van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.
• Background Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
• Background Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.
• Jarzebicka D, Sieczkowska-Golub J, Kierkus J, Czubkowski P, Kowalczuk-Kryston M, Pelc M, Lebensztejn D, Korczowski B, Socha P, Oracz G. PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children: Randomized Study. J Pediatr Gastroenterol Nutr. 2019 Mar;68(3):318-324. doi: 10.1097/MPG.0000000000002192.

Drugs

Indications