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Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial
Katarzyna Wojtyniak1, Andrea Horvath1, Piotr Dziechciarz1
1Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
Insights
Lactobacillus casei rhamnosus Lcr35 (Lcr35) did not prove more effective than placebo for treating functional constipation in young children. Current evidence does not support using probiotics for childhood constipation.
Area of Science:
- Pediatrics
- Gastroenterology
- Microbiology
Background:
- Functional constipation is a common pediatric issue.
- Probiotics are explored as a potential treatment for childhood constipation.
- Lactobacillus casei rhamnosus Lcr35 (Lcr35) is a specific probiotic strain.
Purpose of the Study:
- To evaluate the efficacy of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in managing functional constipation in children under 5 years old.
- To compare Lcr35 treatment against a placebo in a pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 94 children aged under 5 years with functional constipation.
- Participants received either Lcr35 (8 × 10^8 CFU) or placebo twice daily for 4 weeks.
- Treatment success was defined as achieving 3+ spontaneous stools per week without fecal soiling in the final week.
Main Results:
- No significant difference in treatment success was observed between the Lcr35 and placebo groups (P=.4).
- Both groups showed a significant increase in defecation frequency from baseline.
- However, the placebo group exhibited a significantly greater defecation frequency than the Lcr35 group throughout the 4-week study period.
Conclusions:
- Lactobacillus casei rhamnosus Lcr35 (Lcr35) as a sole treatment is not more effective than placebo for functional constipation in children under 5.
- This study's findings support current recommendations against the use of probiotics for treating childhood constipation.
Objective:
To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children.
Study Design:
A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged <5 years with functional constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 108 colony-forming units, n = 48) or placebo (n = 46), twice daily, for 4 weeks. The primary outcome measure was treatment success, defined as 3 or more spontaneous stools per week, without episodes of fecal soiling, in the last week of the intervention. Analyses were by intention to treat.
Results:
Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P < .001) and in the Lcr35 group (2.0 [1.0, 2.0] to 4.0 [3.0, 5.0], P < .001), but the defecation frequency in the placebo group was significantly greater than that in the Lcr35 group at weeks 1, 2, 3, and 4.
Conclusion:
Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation in children <5 years. This study adds to current recommendations that do not support the use of probiotics in the treatment of childhood constipation.
Trial Registration:
ClinicalTrials.gov: NCT01985867.
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