Trial reportBMC pediatrics2024
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.
Trial report in BMC pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03993301 (The Impact of Infant Formula With Probiotics on Infants Health), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Impact of Infant Formula With Probiotics on Infants Health
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The role of breastfeeding in modulating antimicrobial resistance in neonates: a systematic review.Pediatric research · 2026Pooled it
- Probiotics in infants for prevention of allergic disease.The Cochrane database of systematic reviews · 2025Pooled it
- Multi-Omics Analysis Reveals the Potential Preventive Mechanism of Lactobacillus salivarius Li01 Against L-Arginine-Induced Acute Pancreatitis in Mice.Microbial biotechnology · 2026Article
- Beyond breastfeeding: a One Health Decalogue for nurturing the infant microbiota.Frontiers in nutrition · 2026Review
- The role of the gut microbiota during the first 2 years of life in the early programming of obesity, type 2 diabetes, and hypertension.Frontiers in nutrition · 2026Review
- Bifidobacteria and Celiac Disease: Mechanisms of Probiotic Action in Reducing Gluten-Induced Cytotoxicity and Inflammation.Molecular nutrition & food research · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBreast milk is a natural treasure for infants, and its microbiota contains a rich array of bacterial species. When breastfeeding is not possible, infant formula with probiotics can be used as a sole source or as a breast milk supplement. The main aim of this study was to evaluate the growth outcomes and tolerance of infants consuming an infant formula containing Bifidobacterium animalis ssp. lactis CP-9 (B. animalis CP-9) or Lactobacillus salivarius AP-32 (L. salivarius AP-32), which were isolated from breast milk and the guts of healthy infants. The safety of these strains in terms of antibiotic resistance and their ability to modulate the gut microbiota were also evaluated.
methodsOne hundred eighty healthy infants were included in this study and separated into three groups: the control group, the L. salivarius AP-32 group, and the B. animalis CP-9 group. In this clinical study, adverse events, growth effects, and the incidence of allergies and gastrointestinal disorders in infants consuming infant formula containing B. animalis CP-9 or L. salivarius AP-32 were evaluated. Finally, the impact of the probiotic infant formula on the gut microbiota was elucidated via next-generation sequencing (NGS) analysis.
resultsThe 4-month interventional study revealed that body weight, recumbent length, and head circumference were similar among the three groups. No adverse events related to the intervention were observed. The microbiota composition was more diverse on day 0 and became more uniform by month 4. B. animalis CP-9 and L. salivarius AP-32 were found to be susceptible to streptomycin, tetracycline, erythromycin, clindamycin, chloramphenicol, and ampicillin.
conclusionsThe use of infant formula containing B. animalis CP-9 and L. salivarius AP-32 was considered safe and well tolerated, with no adverse events observed during the study. While these strains showed low antibiotic resistance and no immediate concerns related to antibiotic resistance genes, further research is needed to comprehensively assess their long-term safety and efficacy and the potential risk of horizontal gene transfer in broader contexts.
trial registrationThe trial was registered with the US Library of Medicine (clinicaltrials.gov) with the number NCT03993301 on 20/06/2019.
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