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Published on: January 27, 2019
Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled
Camille Jung1, Nicolas Kalach2, Vanessa Degas3
1Clinical Research Center, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
Insights
This study found that Limosilactobacillus reuteri (L. reuteri) did not effectively treat chronic functional constipation in young children. The probiotic showed no significant improvement in bowel movements or stool consistency compared to placebo.
Area of Science:
- Pediatrics
- Gastroenterology
- Microbiology
Background:
- Chronic constipation is a prevalent pediatric condition requiring long-term laxative use.
- Preliminary research suggested Limosilactobacillus reuteri (L. reuteri) as a potential treatment for childhood constipation.
- Further investigation was needed to validate these initial findings.
Purpose of the Study:
- To evaluate the efficacy of L. reuteri in treating chronic functional constipation in infants and young children.
- To compare the effects of L. reuteri against a placebo in a pediatric population.
Main Methods:
- A prospective, double-blind, randomized, placebo-controlled trial was conducted across 5 French pediatric departments.
- 49 children aged 6 months to 4 years with chronic constipation received either L. reuteri (10^8 CFU/day) or placebo for 4 weeks.
- Clinical assessments and daily parental records of spontaneous bowel movements, stool consistency, and laxative use were collected at 4 and 8 weeks.
Main Results:
- While the number of spontaneous bowel movements (SBMs) showed slight changes favoring the control group at week 4 and the test group at week 8, these differences were not clinically significant.
- No significant differences were observed between groups at week 4 regarding responder rates (≥3 stools/week without incontinence), rescue medication use, pain scores, or stool consistency.
- The study did not demonstrate a statistically significant benefit of L. reuteri over placebo for the primary or secondary outcomes.
Conclusions:
- This randomized controlled trial failed to confirm the efficacy of Limosilactobacillus reuteri for treating chronic functional constipation in young children.
- The findings suggest that L. reuteri may not be a beneficial therapeutic option for this pediatric condition.
- Further research may be warranted to explore alternative probiotic strains or treatment strategies for pediatric constipation.
Background:
Chronic constipation is common in children and often requires prolonged laxative treatment. Preliminary studies suggest that the probiotic Limosilactobacillus reuteri (L. reuteri) may be useful in treating constipation in children, but these preliminary results need to be replicated. The objective of this study was to assess the efficacy of L. reuteri in infants and young children with chronic functional constipation.
Methods:
A prospective double-blind randomized placebo-controlled trial was conducted in 5 pediatric departments in France between June 2017 and June 2021. In all, 49 patients-ages 6 months to 4 years, and suffering from chronic constipation per Rome IV criteria-were randomly allocated to the test and control groups. For 4 weeks, all were orally administered 5 daily drops of the test (L. reuteri DSM 17938 at 108 colony-forming units per day) or control (placebo) treatment, respectively. Participants were clinically assessed at 4 and 8 weeks. Parents were asked to daily record the number of spontaneous bowel movements (SBMs), stool consistency, and the use of any additional laxatives. Informed consent was obtained from parents of all recruited patients, and the study was approved by both an ethics committee and the French National Agency for Medicines and Health Products Safety (ANSM). The study is registered on ClinicalTrials.gov (NCT03030664).
Results:
The change in SBMs relative to baseline was greater in the control group at week 4 (control: 0.27 ± 0.5; test: 0.23 ± 0.5; P = 0.01) and in the test group at week 8 (control: 0.26 ± 0.4; test: 0.22 ± 0.5; P = 0.03). At week 4, the groups did not differ in number of responders (≥3 stools per week, with no non-retentive fecal incontinence), use of rescue medication, scoring of pain during defecation (Faces Pain Scale-Revised), or stool consistency (Bristol Stool Form Scale).
Conclusion:
This double-blind randomized controlled trial did not confirm the efficacy of L. reuteri for treatment of chronic functional constipation in young children.
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