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June 17, 2026

Efficacy and Safety of Probiotics, Prebiotics, and Synbiotics: An Umbrella Review of Systematic Reviews and Meta-Analysis of Randomized Controlled Trials

Key Points

To synthesize recent evidence on the efficacy and safety of probiotics, prebiotics, and synbiotics for clinical application.
Literature searches conducted in PubMed, Embase, and Web of Science databases.
Analysis included 128 systematic reviews and meta-analyses of randomized controlled trials since 2023.
Effect estimates and comparison data extracted from meta-analyses.
Certain probiotics significantly reduce necrotizing enterocolitis in infants (event rate not specified).
Probiotics improve glycemic control and lipid profiles in type 2 diabetes mellitus (event rate not specified).
Biotics showed benefits in gastrointestinal disorders, though effects varied by strain and population.

Abstract

CONTEXT: Biotics, which include probiotics, prebiotics, and synbiotics, are widely used for health promotion and disease management, but evidence on their efficacy and safety across populations remains fragmented. OBJECTIVE: To synthesize recent evidence on efficacy and safety of prebiotics, probiotics, and synbiotics to inform clinical application and future research. DATA SOURCES: Literature searches were performed in the PubMed, Embase, and Web of Science databases focusing on biotic interventions and their clinical outcomes across different populations and clinical conditions. Eligible studies were systematic reviews and meta-analyses of randomized controlled trials published since 2023, because more recent reviews incorporate updated trial evidence and reduce duplication of earlier findings. DATA EXTRACTION: Data extracted included general study characteristics, all effect estimates generated by the pairwise meta-analyses, and statistically significant comparison estimates derived from the network meta-analyses. DATA ANALYSIS: Data from 128 systematic reviews and meta-analyses were synthesized. Findings showed that certain probiotics reduce necrotizing enterocolitis in infants and improve glycemic control, lipid profiles, and inflammation in patients with type 2 diabetes mellitus. Benefits were also observed in gastrointestinal disorders (ie, irritable bowel syndrome, inflammatory bowel disease, and constipation), gynecological conditions, and some neurological and psychiatric disorders. However, effects varied by strain, population, and condition. Most biotics were well tolerated; however, safety concerns, such as increased risk of sepsis in vulnerable pediatric populations, were noted. Substantial heterogeneity across studies, particularly in network meta-analyses, limited comparability. CONCLUSIONS: Biotics offer promising but selective clinical benefits depending on the condition and population. Although generally safe, their application should be condition specific. Standardization in future trials is essential to improve comparability and guide evidence-based recommendations for the clinical use of biotics. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration No. CRD420251010116.

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