Long‐term safety and efficacy of perinatal probiotic intervention: Evidence from a follow‐up study of four randomized, double‐blind, placebo‐controlled trials
Abstract
Background: Societies worldwide are faced with a progressive increase in immune‐mediated health problems such as allergic, autoimmune, and inflammatory diseases, as well as obesity. Perinatal administration of specific probiotic bacteria is an attractive approach in reducing the risk of these conditions, but long‐term efficacy and safety data are lacking. The aim here was to evaluate the clinical benefit and long‐term safety of specific probiotics administered during the perinatal period. Methods: The probiotic strains used were Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb‐12, Lactobacillus paracasei ST 11, and Bifidobacterium longum BL 999. The children involved have subsequently undergone prospective long‐term follow‐up. In addition to physical examination, data were collected by structured questionnaires on non‐communicable diseases and continued probiotic use, and growth data from welfare clinics and school nurses. Results: Altogether 303 mother–infant pairs were included in the analysis. Seventy‐six of 163 (47%) children receiving perinatal probiotics had developed allergic disease compared with 79 of 140 (56%) receiving placebo (OR 0.67, 95% confidence intervals [CI] 0.43–1.06, p = 0.09). Fifty‐nine of 133 (44%) children receiving L. rhamnosus GG perinatally had developed allergic disease, OR 0.62, 95% CI 0.38–0.99, p = 0.047, as compared to placebo. We found no differences in growth or non‐communicable disease prevalence between children receiving perinatally probiotics or placebo. Conclusions: Perinatal probiotic administration is safe in long‐term follow‐up. Children receiving L. rhamnosus GG perinatally tended to have decreased allergy prevalence.
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Studies evaluating rates of childhood obesity following probiotic therapy in the perinatal and infant period have not reported any adverse events with respect to body mass index.
“Importantly, studies evaluating rates of childhood obesity following probiotic therapy in the perinatal and infant period have not reported any AEs with respect to body mass index.133, ,134”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [134]
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- Authors
- Lundelin, K., Poussa, T., Salminen, S., & Isolauri, E.
- Affiliations
- University of Turku (FI)
- Nokia (Finland) (FI)
- Corresponding author
- Lundelin, Krista
- Venue
- Pediatric Allergy and Immunology
- Publisher
- Wiley
- Published
- 2016-12-23
- Volume
- 28
- Issue
- 2
- Pages
- 170-175
- ISSN
- 0905-6157 (ISSN-L)
- 1399-3038
- OpenAlex
- W2538235360
- Cited by
- 56
- References
- 29
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 6 · 2023: 8 · 2022: 2 · 2021: 3 · 2020: 13 · 2019: 7 · 2018: 6 · 2017: 6
- FWCI
- 7.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pediatric Allergy and Immunology (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 › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Keywords
- probiotic safety, long-term follow-up, allergic diseases, Lactobacillus rhamnosus GG, Bifidobacterium animalis subsp. lactis BB-12, pediatric allergy, non-communicable diseases, child growth, maternal probiotic supplementation
- MeSH terms
- Bifidobacterium longum, Lacticaseibacillus paracasei, Bifidobacterium animalis, Adolescent, Child, Child, Preschool, Double-Blind Method, Female, Finland, Follow-Up Studies, Humans, Hypersensitivity, Infant, Infant, Newborn, Mothers, Placebos, Prospective Studies, Time Factors, Prevalence, Perinatal Care, Probiotics, Lacticaseibacillus rhamnosus
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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