Probiotics in pediatric functional abdominal pain disorders: a systematic review and meta-analysis

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract; statistical significance implied by reported NNT with confidence interval excluding null

• Effect Size: Modest reductions in pain intensity and weekly pain episodes; complete resolution rate difference of approximately 12.5 percentage points favouring probiotics. When success was defined by author-defined improvement thresholds, no significant difference between probiotics and placebo was observed.

• Primary Outcome: Complete symptom resolution: 35.3% in probiotic group versus 22.8% in placebo group

• Nnt Or Sensitivity: NNT = 7 (95% CI 3.97–29.04) for complete symptom resolution; the wide interval reflects substantial imprecision and should be interpreted cautiously in clinical decision-making

• Confidence Interval: NNT 95% CI: 3.97 to 29.04

Clinical Application

Probiotics are widely available, generally well-tolerated, and carry a favourable safety profile in immunocompetent children. However, the optimal strain, dose, and treatment duration remain undefined. The NNT of 7 is clinically meaningful but the wide confidence interval (3.97–29.04) and low-to-moderate evidence certainty necessitate individualised, shared decision-making. Probiotics should be positioned as adjunctive therapy within a broader biopsychosocial management framework rather than as first-line monotherapy. In Australia, paediatric FAPDs are managed within the RACGP and paediatric gastroenterology frameworks, with increasing recognition of the gut-brain axis in childhood functional disorders. Probiotics are not currently listed on the Pharmaceutical Benefits Scheme (PBS) for this indication and are available over-the-counter at variable cost, which may affect equitable access. The TGA regulates probiotics as complementary medicines under the ARTG, meaning strain-specific efficacy claims require careful scrutiny. Australian paediatric gastroenterologists should note alignment with ESPGHAN/NASPGHAN 2025 guidelines, which recommend probiotics as a potential adjunct with low-to-moderate evidence. Clinicians should counsel families that probiotic products vary substantially in strain composition and that the evidence does not yet support a specific product recommendation. Cost-effectiveness data in the Australian context are absent. Children under 18 years with Rome-criteria-diagnosed AP-DGBIs (IBS, FAP-NOS, functional dyspepsia, abdominal migraine) in whom organic pathology has been excluded. The evidence base is most applicable to school-aged children and adolescents, consistent with the typical epidemiology of paediatric FAPDs.

Abstract

UNLABELLED: Functional abdominal pain disorders (FAPDs), currently referred to as abdominal pain-related disorders of gut-brain interaction (AP-DGBIs), are characterized by recurrent abdominal discomfort in children that cannot be fully explained by an identifiable organic disorder. Probiotics are increasingly used as microbiota-targeted treatments, although their true clinical benefit remains uncertain. The objective of this study is to evaluate the efficacy and safety of probiotic supplementation compared with placebo in children with AP-DGBIs. PubMed, Embase, Web of Science and Scopus were searched from the start of each database to April 2026; the review followed PRISMA guidelines. Randomized controlled trials in patients < 18 years with FAPDs (IBS, FAP-NOS, functional dyspepsia, abdominal migraine) diagnosed by Rome II-IV, in which probiotic supplementation was evaluated. Two reviewers independently extracted data and assessed risk of bias using RoB2 tool. Meta-analyses and network meta-analyses were used to synthesize the data; the certainty of the evidence was evaluated using GRADE and CINeMA. This review covers 21 trials (2005-2025) with 1899 patients treatments completed. Probiotics modestly reduced pain intensity and weekly pain episodes, and modestly increased the rate of complete symptom resolution compared with placebo. Treatment with probiotics was associated with complete symptom resolution in 35.3% versus 22.8% of placebo-treated patients, corresponding to a number needed to treat (NNT) of 7 (95%CI = 3.97-29.04). However, the certainty of evidence was rated as low to moderate across outcomes. Moreover, from a clinical perspective, when success was defined as an improvement in symptoms according to an author-defined threshold, probiotic supplementation was not associated with different response rates compared with placebo. CONCLUSION: Probiotics provide modest symptom relief in pediatric FAPDs and may be considered a safe adjunctive therapy rather than a stand-alone treatment. While these findings are in line with the ESPGHAN/NASPGHAN 2025 guidelines, larger standardized trials are required to define optimal strain selection, dosage and treatment duration. TRIAL REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251149947 , identifier CRD420251149947. WHAT IS KNOWN: • AP-DGBIs (formerly FAPDs) are common childhood disorders characterized by recurrent abdominal pain without identifiable organic disease. • Probiotics are increasingly used to restore gut microbial balance, but their clinical benefit remains uncertain. WHAT IS NEW: • Our meta-analysis showed that probiotic supplementation reduced pain intensity and weekly pain episodes and increased symptom resolution versus placebo. • Benefi ts were modest, with substantial heterogeneity across studies and low-to-moderate certainty of evidence.

References

1. 1.Balasan, N., Kharrat, F., Lega, S., Di Leo, G., D'Adamo, A. P., Comar, M., Barbi, E., & Zupin, L. (2026). Probiotics in pediatric functional abdominal pain disorders: a systematic review and meta-analysis. European Journal of Pediatrics. https://doi.org/10.1038/s41575-020-0344-2