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Abstract

Background & aims: Possible therapeutic effect of Lactobacillus (L.) reuteri DSM 17938 has been reported in children with functional abdominal pain (FAP) but data are inconclusive.

Methods: This is a randomized double-blinded controlled trial (RCT) which assessed effect of L. reuteri DSM 17938 (dose 108 CFU/day) in children (age 4-18 years) on FAP during an intervention period of 12 weeks and follow-up of 4 weeks. This study was performed after the interim analysis and had different labeling of products and a new randomization. Data presented here are results of this RCT and pooled data from both RCTs (before and after interim analysis).

Results: This RCT included 46 children (median age 10.1 vs 10.6 years; 11 vs 13 girls). Abdominal pain was less severe in intervention group during the 4th month of the study and there was significant increase in the number of days without pain. Pooled data from both parts of the study included 101 children. Number of days without pain was significantly higher in the L. reuteri group (mean difference 26.42 days, 95% CI 22.47-30.17). Significant difference in the pain intensity was found after 2nd, 3rd and 4th month of the intervention. There was no difference between groups in the number of children in whom symptoms completely ceased (Risk Ratio 1.09, 95% CI 0.75-1.58).

Conclusion: Administration of L. reuteri DSM 17938 was associated with the reduction in the intensity of pain and with significantly increase in pain-free days in children with FAP.

Keywords: Abdominal pain; Children; Functional gastrointestinal disorders; L. reuteri DSM 17938; Probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus reuteriIncreased Pain-Free DaysBeneficial
Large
Lactobacillus reuteriReduced Abdominal Pain SeverityBeneficial
Moderate
Lactobacillus reuteri ATCC PTA 5289Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri ATCC PTA 5289Reduced Pain IntensityBeneficial
Moderate
Lactobacillus reuteri DSM 17938Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri DSM 17938Reduced Abdominal PainBeneficial
Moderate
Lactobacillus reuteri HA-188Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri HA-188No Change in Complete Symptom CessationNeutral
Small
Lactobacillus reuteri HA-188Reduced Abdominal Pain IntensityBeneficial
Moderate
Lactobacillus reuteri LRE02Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri LRE02Reduced Abdominal Pain SeverityBeneficial
Moderate
Lactobacillus reuteri MAK02L14RIncreased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri MAK02L14RReduced Pain IntensityBeneficial
Moderate
Lactobacillus reuteri NCIMB 30242Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri NCIMB 30242Reduced Abdominal Pain IntensityBeneficial
Moderate
Lactobacillus reuteri OsfortisIncreased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri OsfortisReduced Abdominal Pain SeverityBeneficial
Moderate
Lactobacillus reuteri RC-14Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri RC-14Reduced Pain IntensityBeneficial
Moderate
Lactobacillus reuteri SD-5865Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri SD-5865Reduced Abdominal Pain IntensityBeneficial
Moderate
Lactobacillus reuteri UALg-05Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri UALg-05Reduced Pain IntensityBeneficial
Moderate
Lactobacillus reuteri UALre-16Increased Pain-Free DaysBeneficial
Large
Lactobacillus reuteri UALre-16Reduced Abdominal PainBeneficial
Moderate
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