Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

The effectiveness of Lactobacillus reuteri DSM 17938 as an adjunct to macrogol in the treatment of functional constipation in children. A randomized, double-blind, placebo-controlled, multicentre trial.

  • 2018-10
  • Clinics and research in hepatology and gastroenterology 42(5)
    • Agnieszka Wegner
    • Aleksandra Banaszkiewicz
    • Jaroslaw Kierkus
    • Piotr Landowski
    • Anna Korlatowicz-Bilar
    • Sabina Wiecek
    • Jaroslaw Kwiecien
    • Agnieszka Gawronska
    • Lukasz Dembinski
    • Grazyna Czaja-Bulsa
    • Piotr Socha

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 129
Population
129 children with functional constipation who were treated with a poor effect for at least two months prior to the study
Methods
double-blind, placebo-controlled, randomized, multicentre trial; patients randomly assigned to L. reuteri DSM 17938 and macrogol or macrogol and matching placebo for 8 weeks
Blinding
Double-blind
Duration
8 weeks
Funding
Unclear
  • Large Human Trial

Objective

Constipation is one of the most common problems among children, with a prevalence ranging from 7 to 30%. It is treated with defecation training and laxative medications. However, many patients do not respond to the standard therapy. There is, therefore, an increasing interest in probiotics for the treatment of functional constipation.

Study design

The aim of this study was to assess the effectiveness of Lactobacillus reuteri DSM 17938 as an adjunct to macrogol in the treatment of functional, intractable constipation in children. A double-blind, placebo-controlled, randomized, multicentre trial involved a group of 129 children with functional constipation who were treated with a poor effect for at least two months prior to the study. Patients were randomly assigned to one of the two groups: 1. L. reuteri DSM 17938 and macrogol or 2. macrogol and matching placebo for 8 weeks.

Results

121 patients completed the study. Almost all patients (119/129) increased their bowel movements in both groups (59 vs 60, ns.) and there was no statistically significant difference in the number of bowel movements per week in week 8 between the study and the placebo group (7.5±3.3 vs 6.9±2.5, respectively). Additionally, there were no significant differences between groups in the numbers of patients complaining of pain during defecation (13/47 vs 8/53), abdominal pain (19/41 vs 25/36), withholding stools (15/45 vs 13/48), passing hard stools (7/53 vs 3/58) or large stools (14/46 vs 12/49), and faecal incontinence (17/43 vs 11/50).

Conclusion

L. reuteri DSM 17938 supplementation as an additional therapy to macrogol did not have any beneficial effect on the treatment of functional constipation in children aged 3-7 years.

Research Insights

Back to top