Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Apr 11;16(8):1134.
doi: 10.3390/nu16081134.

Evaluation of Safety and Beneficial Health Effects of the Human-Milk Strain Bifidobacterium breve DSM32583: An Infant Pilot Trial

Claudio Alba  1 , Marta Carrera  2 , Guillermo Álvarez-Calatayud  3 , Rebeca Arroyo  1 , Leónides Fernández  4 , Juan M Rodríguez  1
Affiliations
Randomized Controlled Trial

Evaluation of Safety and Beneficial Health Effects of the Human-Milk Strain Bifidobacterium breve DSM32583: An Infant Pilot Trial

Claudio Alba et al. Nutrients. .

Abstract

Human milk promotes the growth of bifidobacteria in the infant gut. Adding bifidobacterial species to infant formula may contribute to increasing their presence in the gut of formula-fed infants. Therefore, the safety and anti-infectious effects of Bifidobacterium breve DSM32583, a breast milk isolate, were assessed in a pilot trial involving 3-month-old infants. The infants were randomly assigned to either the probiotic (PG) or the control (CG) groups. All the infants consumed the same formula, although it was supplemented with the strain (1 × 107 cfu/g of formula) in the PG. Overall, 160 infants (80 per group) finished the intervention. Infants in CG gained more weight compared to PG (p < 0.05), but the weights for age Z-scores at 6 months were within the normal distribution for this age group. The rates of infections affecting the gastrointestinal and respiratory tracts and antibiotic therapy were significantly lower in the PG. The bifidobacterial population and the level of short-chain fatty acids were higher (p < 0.05) in the fecal samples of PG infants. No adverse events related to formula consumption were observed. In conclusion, the administration of an infant formula with B. breve DSM32583 was safe and exerted potential beneficial effects on gut health.

Keywords: Bifidobacterium breve; bifidobacteria; infant formula; infections; probiotics; safety; short-chain fatty acids.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest. After the assay was completed, the strain was transferred to HiPP GmbH and Co. Vertrieb KG (Pfaffenhofen, Germany), an infant nutrition company. The company had no role in the study design, data collection, or analysis, but was involved in the writing of the manuscript.

Figures

Figure 1
Figure 1
Flow chart of infants participating in the study. ASE, all subjects enrolled; ASR, all subjects randomized; mITT (modified intention-to-treat).
Figure 2
Figure 2
Median bifidobacterial counts in fecal samples of infants (as log10 cfu/g) (A), and fecal concentration of short-chain fatty acids (mg/g feces) (B–D) at 3 and 6 months of age. Mann–Whitney U was used to evaluate differences in median values between the control and probiotic groups at 6 months. Data expressed as median (IQR). ***, p < 0.05.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Milani C., Duranti S., Bottacini F., Casey E., Turroni F., Mahony J., Belzer C., Delgado Palacio S., Arboleya Montes S., Mancabelli L., et al. The first microbial colonizers of the human gut: Composition activities, and health implications of the infant gut microbiota. Microbiol. Mol. Biol. Rev. 2017;81:e00036–e00117. doi: 10.1128/MMBR.00036-17. - DOI - PMC - PubMed
    1. Newburg D.S., Morelli L. Human milk and infant intestinal mucosal glycans guide succession of the neonatal intestinal microbiota. Pediatr. Res. 2015;77:115–120. doi: 10.1038/pr.2014.178. - DOI - PubMed
    1. Pannaraj P.S., Li F., Cerini C., Bender J.M., Yang S., Rollie A., Adisetiyo H., Zabih S., Lincez P.J., Bittinger K., et al. Association between breast milk bacterial communities and establishment and development of the infant gut microbiome. JAMA Pediatr. 2017;171:647–654. doi: 10.1001/jamapediatrics.2017.0378. - DOI - PMC - PubMed
    1. Le Doare K., Holder B., Bassett A., Pannaraj P.S. Mother’s Milk: A purposeful contribution to the development of the infant microbiota and immunity. Front. Immunol. 2018;9:361. doi: 10.3389/fimmu.2018.00361. - DOI - PMC - PubMed
    1. Goldman A.S. Future research in the immune system of human milk. J. Pediatr. 2019;206:274–279. doi: 10.1016/j.jpeds.2018.11.024. - DOI - PubMed

Publication types

Substances

-