Assessment of the safety and gut microbiota modulation ability of an infant formula containing Bifidobacterium animalis ssp. lactis CP-9 or Lactobacillus salivarius AP-32 and the effects of the formula on infant growth outcomes: insights from a four-month clinical study in infants under two months old
2024

Safety and Effects of Probiotic Infant Formula on Growth

Sample size: 180 publication 10 minutes Evidence: moderate

Author Information

Author(s): Shen Shang-Po, Lin Hung-Chih, Chen Jui-Fen, Wang Hui-Shan, Huang Yen-Yu, Hsia Ko-Chiang, Lin Jia-Hung, Kuo Yi-Wei, Li Ching-Min, Hsu Yu-Chieh, Tsai Shin-Yu, Ho Hsieh-Hsun

Primary Institution: China Medical University Children's Hospital

Hypothesis

Does an infant formula containing Bifidobacterium animalis CP-9 or Lactobacillus salivarius AP-32 affect infant growth outcomes and gut microbiota?

Conclusion

The probiotic infant formula was safe and well tolerated, with no adverse events observed and no significant impact on growth outcomes.

Supporting Evidence

  • The study included 180 healthy infants, ensuring a robust sample size for analysis.
  • No adverse events related to the intervention were observed during the study.
  • Growth metrics such as body weight, length, and head circumference were similar across all groups.
  • The probiotic strains showed low antibiotic resistance, indicating safety for infant consumption.
  • Microbiota analysis revealed changes over time, suggesting modulation by the formula.

Takeaway

This study tested a special baby formula with good bacteria to see if it helps babies grow and stay healthy, and it found that it was safe to use.

Methodology

A double-blind randomized trial with 180 healthy infants divided into three groups: control, L. salivarius AP-32, and B. animalis CP-9, monitored for growth and adverse events over four months.

Potential Biases

Potential bias due to the dropout rates and the subjective nature of parental reporting on infant health.

Limitations

The study had a dropout rate that affected the statistical power, particularly in the L. salivarius AP-32 group.

Participant Demographics

Healthy infants under two months old, born at term, with a slight majority of females in the AP-32 group.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/s12887-024-05289-7

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication