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Randomized Controlled Trial
. 2025 Jan;155(1):144-152.
doi: 10.1016/j.jaci.2024.08.009. Epub 2024 Aug 21.

Effects of pregnancy and lactation prebiotics supplementation on infant allergic disease: A randomized controlled trial

Debra J Palmer  1 , Alana R Cuthbert  2 , Thomas R Sullivan  3 , Rachelle A Pretorius  4 , Johan Garssen  5 , Kristina Rueter  6 , Maria C Jenmalm  7 , Jeffrey A Keelan  8 , Desiree Silva  9 , Susan L Prescott  10
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Free article
Randomized Controlled Trial

Effects of pregnancy and lactation prebiotics supplementation on infant allergic disease: A randomized controlled trial

Debra J Palmer et al. J Allergy Clin Immunol. 2025 Jan.
Free article

Abstract

Background: Ingestion of prebiotics during pregnancy and lactation may have immunomodulatory benefits for the developing fetal and infant immune system and provide a potential dietary strategy to reduce the risk of allergic diseases.

Objective: We sought to determine whether maternal supplementation with dietary prebiotics reduces the risk of allergic outcomes in infants with hereditary risk.

Methods: We undertook a double-blind randomized controlled trial in which pregnant women were allocated to consume prebiotics (14.2 g daily of galacto-oligosaccharides and fructo-oligosaccharides in the ratio 9:1) or placebo (8.7 g daily of maltodextrin) powder from less than 21 weeks' gestation until 6 months postnatal during lactation. Eligible women had infants with a first-degree relative with a history of medically diagnosed allergic disease. The primary outcome was medically diagnosed infant eczema by age 1 year, and secondary outcomes included allergen sensitization, food allergy, and recurrent wheeze by age 1 year.

Results: A total of 652 women were randomized between June 2016 and November 2021 (329 in the prebiotics group and 323 in the placebo group). There was no significant difference between groups in the percentage of infants with medically diagnosed eczema by age 1 year (prebiotics 31.5% [103 of 327 infants] vs placebo 32.6% [105 of 322 infants]; adjusted relative risk, 0.98; 95% CI, 0.77-1.23; P = .84). Secondary outcomes and safety measures also did not significantly differ between groups.

Conclusions: We found little evidence that maternal prebiotics supplementation during pregnancy and lactation reduces the risk of medically diagnosed infant eczema by age 1 year in infants who are at hereditary risk of allergic disease.

Keywords: Allergy prevention; eczema; infant; lactation; maternal diet; prebiotics; pregnancy; randomized controlled trial.

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Conflict of interest statement

Disclosure statement This trial was supported by a National Health and Medical Research Council (NHMRC) project grant (grant no. ID1099480) and a Telethon-Perth Children’s Hospital Research Fund grant. D.J.P. was supported by the NHMRC Medical Research Futures Fund Career Development Fellowship (ID1144544) (2018-2021) and the Telethon Kids Institute Ascend Fellowship (2022-2026). T.R.S. was supported by an NHMRC Investigator Grant (grant no. ID1173576). S.L.P. was supported by a fellowship from the Nova Institute for Health. Substantial in-kind support has been provided by Telethon Kids Institute and Joondalup Health Campus. All study powders were manufactured, packaged, and labeled by the independent company, Danone (Utrecht, The Netherlands). The trial was investigator-initiated, and Danone had no other involvement other than the provision of study powders. All funders had no role in the study design nor writing of this trial protocol article. Disclosure of potential conflict of interest: J. Garssen is a part-time employee of Danone Nutricia Research; and receives research funding/grants from the European Union, the Dutch government, Bill Gates Foundation, public and private research funding from the Netherlands, and some companies such as Danone Nutricia Research, Nutricia Research Foundation, Friesland Campina, and DSM. M. C. Jenmalm received funding for a clinical trial; received honoraria for lectures from BioGaia AB; and received consultant fees and travel support from Danone Nutricia and Abigo Medical. S. L. Prescott received speaker fees from Danone Nutricia. The rest of the authors declare that they have no relevant conflicts of interest.

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