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Published on: January 27, 2019
Probiotics in pediatric functional abdominal pain disorders: a systematic review and meta-analysis
Nour Balasan1, Feras Kharrat2,3, Sara Lega1
1Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Via Dell'Istria 65/1, 34137, Trieste, Italy.
Insights
Probiotics offer modest symptom relief for children with abdominal pain-related disorders of gut-brain interaction (AP-DGBIs), showing a slight reduction in pain and increased symptom resolution compared to placebo. However, the evidence is of low to moderate certainty, suggesting they are best used as an add-on therapy.
Area of Science:
- Gastroenterology
- Pediatrics
- Microbiome Research
Background:
- Functional abdominal pain disorders (FAPDs), now termed abdominal pain-related disorders of gut-brain interaction (AP-DGBIs), are prevalent in children, presenting as recurrent abdominal pain without clear organic causes.
- Probiotics are frequently employed for gut microbial balance, yet their actual clinical effectiveness in pediatric AP-DGBIs is not well-established.
Purpose of the Study:
- To systematically evaluate the efficacy and safety of probiotic supplementation versus placebo in children diagnosed with AP-DGBIs.
- To synthesize evidence from randomized controlled trials to inform clinical practice and future research.
Main Methods:
- A comprehensive search of PubMed, Embase, Web of Science, and Scopus was conducted up to April 2026, adhering to PRISMA guidelines.
- Included were 21 randomized controlled trials (2005-2025) involving 1899 pediatric patients (under 18 years) with AP-DGBIs (Rome II-IV criteria).
- Data were extracted and analyzed using meta-analysis and network meta-analysis, with risk of bias assessed by RoB2 and evidence certainty by GRADE and CINeMA.
Main Results:
- Probiotic supplementation demonstrated a modest reduction in pain intensity and weekly pain episodes compared to placebo.
- Complete symptom resolution was observed in 35.3% of probiotic-treated patients versus 22.8% of placebo recipients (NNT=7).
- The certainty of evidence for these outcomes was rated as low to moderate; no significant difference in response rates was found when symptom improvement was defined by author-specific thresholds.
Conclusions:
- Probiotics provide a modest benefit for symptom relief in pediatric AP-DGBIs and can be considered a safe adjunctive therapy.
- Larger, standardized trials are necessary to determine optimal probiotic strains, dosages, and treatment durations for this population.
Abstract:
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.
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