Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy
Open accessAbstract
Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe use, it is important to identify any adverse effects in potentially vulnerable populations. In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 x 10(10) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0-6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires. Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers' assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention. Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.
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In vulnerable patient groups, intestinal barrier dysfunction increases the risk of adverse effects from probiotics.
“In such vulnerable patient groups, intestinal barrier dysfunction increases the risk of adverse effects from probiotics [81] and may contribute to infection development, which can subsequently lead to sepsis or inflammation [19].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [81]
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- Authors
- Allen, S. J., Jordan, S., Storey, M., Thornton, C. A., Gravenor, M., Garaiova, I., Plummer, S. F., Wang, D., & Morgan, G.
- Affiliations
- Swansea University (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Allen, Stephen J.
- Venue
- The Journal of Nutrition
- Publisher
- Elsevier BV
- Published
- 2010-03
- Volume
- 140
- Issue
- 3
- Pages
- 483-488
- ISSN
- 0022-3166 (ISSN-L)
- OpenAlex
- W2014544748
- Cited by
- 119
- References
- 16
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 12 · 2023: 3 · 2022: 7 · 2021: 12 · 2020: 12 · 2019: 7 · 2018: 9 · 2017: 8 · 2016: 6 · 2015: 8 · 2014: 4 · 2013: 8 · 2012: 5
- FWCI
- 9.31
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Health Sciences › Health Professions › Pharmacy › Infant Health and Development
- Keywords
- probiotics, lactobacilli, Bifidobacterium, dietary supplementation, safety, adverse events, atopy prevention, pregnancy, infancy, Lactobacillus salivarius, Lactobacillus paracasei, Bifidobacterium animalis subsp. lactis, Bifidobacterium bifidum, mother-infant dyads
- MeSH terms
- Adult, Bifidobacterium, Double-Blind Method, Female, Humans, Hypersensitivity, Immediate, Infant, Infant, Newborn, Lactobacillus, Pregnancy, Pregnancy Trimester, Third, Dietary Supplements, Probiotics
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