Lack of Benefit of Lactobacillus Reuteri DSM 17938 as an Addition to the Treatment of Functional Constipation

The aim of this study was to investigate the role of Lactobacillus (L.) reuteri DSM 17983 in the treatment of functional constipation in children. The trial was a single-center randomized, double-blind, placebo-controlled study. Patients were allocated into the two groups; intervention group which received L. reuteri DSM 17983 and lactulose and placebo group which received placebo and lactulose. Due to small recruitment rate study was terminated prematurely, therefore only 33 children (12 girls, median age 4.5 years, range 2–16) were randomized. There was no difference between groups in the stool frequency, stool consistency, pain, soiling rate and dose of the lactulose. This study found that L. reuteri DSM 17938 adds no benefit to the treatment of constipation in children. However, due to small sample size these results should be interpreted with caution. Address correspondence and reprint requests to Iva Hojsak, MD, PhD, Referral Center for Pediatric Gastroenterology and Nutrition, Children's Hospital Zagreb, Klaiceva 16, 10000 Zagreb, Croatia (e-mail: ivahojsak@gmail.com). Received 5 May, 2018 Accepted 1 August, 2018 This trail has been registered at ClinicalTrials.gov (NCT01587846) Funding Source: No funding was allocated for this study. Support of the study: For the purpose of the study both probiotic preparation and placebo were supplied by probiotic strain producer BioGaia, Stockholm, Sweden. BioGaia had no involvement in the study design, the collection, analysis, and interpretation of data, writing of the report and the decision to submit the paper for publication. Conflict of interest statement: Iva Hojsak in the last 2 years received speakers grants from BioGaia, Nutricia, Medis Adria, Pharmas. Oleg Jadrešin received speakers grants from BioGaia. Zrinjka Mišak has in the last 2 years received speakers grants from Pharmas. Sanja Kolaček participated as a clinical investigator, and/or speaker for Abbott, Arla, Biogaia, Chr. Hansen, Danone, Dukat, Nestlé, Nutricia, and MSD. Sara Sila has no conflict of interest. Ivana Trivić has no conflict of interest. Authors Contributions: Concept and design of the study OJ, IH; conduction of the study SS, IT, ZM; analysis of the data IH; interpretation of the data OJ, IH, SK; Drafting of the manuscript SS, IT, IH, OJ; critical analysis of the manuscript ZM, SK; final approval of the manuscript all authors. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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