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Effectiveness and safety study of formula containing probiotics, prebiotics, synbiotics on fullterm infants’ growth - a systematic review and meta-analysis of randomized controlled study

European Journal of Clinical Nutrition volume 79, pages 504–511 (2025)Cite this article

Subjects

Abstract

Background and Objective

Probiotics, prebiotics, and synbiotics, are hot topics of research and have been shown to improve the body’s disease state and promote health. Analysis of whether infant formula containing probiotcs, prebiotics, synbiotics is beneficial to infant and child growth.

Methods

We systematically searched multiple electronic databases (PubMed, Web of Science, The Cochrane Library, Embase) to identify eligible studies published from 1966 to December 25, 2022. Included studies were randomized controlled trials (RCTs) studying the influence of milk powder containing probiotcs, prebiotics, synbiotics on infants and children’s growth. RevMan 5.4 was used to analyze the data.

Results

A total of 55 RCTs with a total sample size of 8868 participants met the inclusion criteria. Milk powder with probiotics, prebiotics, synbiotics does not significantly improve the growth of infants and children (Weight, height, BMI, and Head Circumference); The incidence of minor adverse events (OR 0.88, 95% CI 0.70–1.11 P = 0.28) and serious adverse events (OR 0.92, 95% CI 0.62–1.36 P = 0.67) was also comparable to the control group; The intestinal microbial diversity of infants consuming probiotcs, prebiotics, synbiotics supplemented formula was lower than that of infants consuming formula without probiotcs, prebiotics, synbiotics (SMD –0.88, 95% CI –1.66- –0.1 P = 0.03), but the abundance of individual beneficial flora was increased. (SMD 1.62, 95%CI 0.61–2.62 P = 0.002). In particular, the abundance of Lactobacillus (SMD 1.62, 95% CI 0.61–2.62 P = 0.002). For metabolites, synbiotics increased fecal antibody concentrations (SMD 0.47, 95% CI 0.08-0.86 P = 0.02), but fecal short-chain fatty acid concentrations remained balanced in both groups (SMD 0.05 95% CI –0.17–0.28 P = 0.64). Compared to the control group, infants who consumed formula with prebiotics had softer stools (SMD −1.47, 95% CI −2.23 to −0.7 P = 0.002) and lower stool pH (SMD −0.82, 95% CI −1.15- −0.5 P < 0.00001), there is also more frequency of bowel movements (SMD 0.27, 95% CI 0.09–0.44 P = 0.002).

Conclusions

Probiotcs, prebiotics, synbiotics supplemented formulas significantly increased abundance of individual probiotics, alter intestinal antibody secretion, and improve bowel movements. Incidence of adverse reactions did not differ between the two groups. So we can choose formula-supplemented probiotcs, prebiotics, synbiotics to maintain the intestinal health of infants.

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Fig. 1
Fig. 2: Meta-analysis of influence of probiotics, prebiotics, synbiotics on infants’  safety.
Fig. 3: Meta-analysis of influence of probiotics, prebiotics, synbiotics on the count of Lactobacillus.
Fig. 4: Meta-analysis of influence of prebiotic on Stool frequency.
Fig. 5: Meta-analysis of influence of prebiotic on Stool consistency.
Fig. 6: Meta-analysis of influence of prebiotic on Stool pH.

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Author notes

  1. These authors contributed equally: Jiafen Qian, Zongwei Fang, Sijie Chang.

Authors and Affiliations

  1. Department of Pharmacy, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China

    Jiafen Qian, Zongwei Fang, Sijie Chang, Zhiwei Zeng & Jinhua Zhang

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  1. Jiafen Qian
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  2. Zongwei Fang
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  3. Sijie Chang
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  4. Zhiwei Zeng
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  5. Jinhua Zhang
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Contributions

JZ initiated the study. JQ, ZF performed data extraction and analyses, JQ drafted the first version of the manuscript. JZ, SC and ZF critically reviewed the manuscript and revised it. ZZ, SC Performed all verification work. All authors made a substantial contribution to the concept and design of the study, interpreted the data, and reviewed the manuscript. Sijie Chang, Zongwei Fang and Jiafen Qian contributed equally to the article.

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Correspondence to Jinhua Zhang.

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Qian, J., Fang, Z., Chang, S. et al. Effectiveness and safety study of formula containing probiotics, prebiotics, synbiotics on fullterm infants’ growth - a systematic review and meta-analysis of randomized controlled study. Eur J Clin Nutr 79, 504–511 (2025). https://doi.org/10.1038/s41430-024-01506-9

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  • DOI: https://doi.org/10.1038/s41430-024-01506-9

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