Safety Profile of Probiotics as an Adjuvant to Oral Immunotherapy for Food Allergies: A Meta Analysis of Randomized Controlled Trials

TL;DR

This study finds that combining probiotics with allergen immunotherapy for food allergies is generally safe, with no major differences in adverse events compared to a placebo.

Contribution

The paper provides a meta-analysis evaluating the safety of probiotics as an adjuvant to allergen immunotherapy for food allergies.

Findings

The combination of probiotics and allergen immunotherapy showed a favorable safety profile.

There was no significant difference in adverse events between the probiotics and placebo groups for most organ systems.

A potential increase in oral adverse effects was observed in the probiotics group, though not statistically significant.

Abstract

Food allergies are common, affecting a sizable portion of children and adults in the Western world. In recent years, a promising treatment known as allergen immunotherapy (AIT) has emerged. This technique aims to address the fundamental immune system dysfunction that underlies food allergies. The study's objective was to evaluate the safety of combining probiotics with AIT, compared to placebo in treating patients with food allergies. A comprehensive literature search in several databases was conducted. All included studies were randomized controlled trials(RCTs). Meta-analyses were performed using R software. Statistical tests to assess safety outcomes and risk of bias were used. After reviewing 519 studies, three studies were included in the systematic review and meta-analysis, involving a total of 258 patients (141 in the probiotics group, 144 in the placebo group). The evaluation of the safety profile of the integrated probiotic therapy revealed an overall favorable outcome, with no significant differences in adverse events compared to placebo for most organ systems examined. However, a potential increase in oral adverse effects was observed in the probiotics group (RR = 1.7573, 95% CI: 0.3941 to 7.8359), although this result did not reach statistical significance. The combination of probiotics and allergen-specific immunotherapy appears to be generally safe and shows promise as a valuable treatment approach.

The online version contains supplementary material available at 10.1007/s12602-025-10544-z.

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