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Randomized Controlled Trial
. 2025 Aug;80(8):2158-2166.
doi: 10.1111/all.16634. Epub 2025 Jun 27.

Effect of the Multi-Strain Probiotic SYN-53 in the Management of Allergic Rhinoconjunctivitis

Affiliations
Randomized Controlled Trial

Effect of the Multi-Strain Probiotic SYN-53 in the Management of Allergic Rhinoconjunctivitis

Karl-Christian Bergmann et al. Allergy. 2025 Aug.

Abstract

Dysbiosis is increasingly linked to allergy development. This study evaluates the efficacy of the multi-strain probiotic SYN-53 in the management of allergic rhinoconjunctivitis (ARC). Eighty-four subjects with confirmed grass pollen allergy underwent up to three bi-weekly 3-day intake cycles with SYN-53 or placebo. After each cycle, subjects were exposed to grass pollen in an allergen exposure chamber. ARC symptoms were assessed using the Total Symptom Score (TSS) before and after each use of SYN-53. After one intake cycle, SYN-53 already showed a trend towards greater efficacy over placebo, which became significant after two cycles (ΔTSSMAX: -3.44 ± 0.42 vs. -1.87 ± 0.37; p = 0.0067), with 38% vs. 24% symptom relief. In subjects with moderate to severe symptoms, SYN-53 was already significantly superior after one single intake cycle and improved further after two cycles (ΔTSSMAX: -4.78 ± 0.51 vs. -2.43 ± 0.47; p = 0.0014), with 45% vs. 26% symptom relief. SYN-53 is effective in the management of ARC, highlighting the role of bacterial diversity and dosage in probiotic nutritional supplements.

Keywords: allergen exposure chamber; allergic rhinitis; allergic rhinoconjunctivitis; microbiome; probiotic.

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Conflict of interest statement

The European Centre for Allergy Research Foundation (ECARF) received reimbursement for participating as a study center. K.‐C.B. received honoraria for lectures from ALK, Allergopharma, Almirall, AstraZeneca, Bencard, Berlin‐Chemie, Chiesi, GSK, HAL, Mundipharma, Novartis, Sanofi, and Stallergenes during the last 5 years. T.Z. has received institutional funding for research and/or honoria for lectures and/or consulting from Amgen, AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bayer Health Care, Bencard, Berlin Chemie, Blueprint Medicines, FAES, HAL, Henkel, Kryolan, Leti, L'Oreal, Meda, Menarini, Merck, MSD, Novartis, Pfizer, Sanofi, Stallergenes, Takeda, Teva and UCB, Uriach; in addition, he is a member of ARIA/WHO, DGAKI, ECARF, GA2LEN and WAO.

Figures

FIGURE 1
FIGURE 1
Timeline of the intake cycles and allergen exposures during the clinical study.
FIGURE 2
FIGURE 2
Overview and results of the intention‐to‐treat (ITT) population. (A) Overview of the subject flow (TSSMAX ≥ 3). (B) Difference in maximum Total Symptom Score (∆TSSMAX) in the ITT population after one, two and three intake cycles. ANCOVA analysis, values shown as mean ± SEM, n(placebo) = 47, n(intervention) = 37.
FIGURE 3
FIGURE 3
Overview and results of the subgroup analysis, with subject cluster TSSMAX ≥ 6. (A) Overview of the subject flow of cluster TSSMAX ≥ 6. (B) Difference in maximum Total Symptom Score (∆TSSMAX) in the cluster TSSMAX ≥ 6 after one, two and three intake cycles. ANCOVA analysis, values shown as mean ± SEM, n(placebo) = 33, n(intervention) = 28.

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