Comparison of Lactobacillus reuteri DSM 17938 versus placebo in the management of functional abdominal pain in children aged 4-12 years: A randomized double-blind placebo-controlled trial

Background: Functional abdominal pain (FAP) and related functional gastrointestinal disorders (FGIDs) are common in children and associated with significant disability. Probiotics, particularly Lactobacillus reuteri DSM 17938, are proposed as a therapeutic option through modulation of gut microbiota and the gut-brain axis. Objectives: To compare the efficacy of L. reuteri DSM 17938 versus placebo in reducing pain frequency and severity in children aged 4-12 years with FAP spectrum disorders. Methods: In this randomized, double-blind, placebo-controlled trial conducted in the Department of Pediatrics, NC Medical College, Israna, Panipat, children aged 4-12 years fulfilling Rome IV criteria for FAP-NOS, IBS, functional dyspepsia, or abdominal migraine and experiencing ≥1 pain episode/week were enrolled. Participants were randomized to receive either L. reuteri DSM 17938 (1 × 10⁸ CFU/day) or identical placebo for 4 weeks, followed by 4 weeks of observation. Pain frequency (episodes/month) and pain intensity (Wong-Baker Faces Scale, WBFS, and Modified WBFS) were assessed at baseline, 4 weeks, and 8 weeks. School absenteeism and safety were also recorded. Results: Of 60 enrolled children, 52 completed the study (25 probiotic, 27 placebo). Baseline demographic, anthropometric, laboratory, and Rome IV subtype distribution were comparable between groups; FAP-NOS was the predominant subtype (84%). Baseline pain frequency was similar (5.64±1.44 vs 6.08±1.78 episodes/month; probiotic vs placebo). At 4 weeks, pain frequency decreased to 2.12±0.78 versus 5.08±1.85 (p<0.01), and at 8 weeks to 1.36±0.57 versus 5.12±1.81 (p<0.01), favoring the probiotic group. WBFS scores fell from 7.64±1.11 to 4.40±1.56 at 4 weeks and 4.80±1.29 at 8 weeks in the probiotic group, compared with 8.16±0.75 to 5.68±0.99 and 6.08±0.91 in the placebo group (both time-points p<0.01). Modified WBFS categories also showed a greater shift toward lower pain scores in the probiotic arm (p<0.01). School absenteeism decreased similarly in both groups without significant between-group differences. No serious adverse events were reported. Conclusions: L. reuteri DSM 17938 significantly reduced pain frequency and intensity compared with placebo in children with FAP spectrum disorders, with effects persisting 4 weeks after discontinuation. The strain appears to be a safe and useful adjunct in the multimodal management of pediatric FAP, although benefits on functional outcomes such as school attendance were modest.

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