Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

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Randomised Controlled TrialEvidence: Moderate
75CEBM

European journal of pediatrics

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

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.

21 July 2026

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