CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
ES1 group +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05208528
NCT05208528N/ACompleted

Effect of the Probiotic Bifidobacterium Longum ES1 and Its Inactivated Form by Heat (HT-Bifidobacterium Longum ES1) Over Symptomatology Asociated With Allergic Rhinitis. Parallel, Randomized, Controled, and Double-Blind Intervention Trial

Fundació Eurecat·interventional·Posted Jan 26, 2022·Updated May 4, 2026

In Brief

A clinical study evaluating ES1 group, HT-ES1 group, and 1 other intervention for Allergic Rhinitis. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Allergic rhinitis (AR) is a health problem characterised by an inflammatory reaction in the nasal mucosa mediated by immunoglobulin (Ig) E and resulting from exposure to environmental allergens, such as pollen and dust mites. AR symptoms can significantly affect the quality of life of patients suffering from AR, causing substantial direct health care costs and indirect costs due to absenteeism from work. The effects of pharmacological treatments are not always fully effective and have adverse effects, resulting in a significant proportion of AR patients continuing to experience symptoms or being dissatisfied. Considering the relationship between AR and intestinal microbiota (IM), the use of probiotics, live microorganisms that, when consumed in adequate amounts, confer beneficial effects on the host, emerges as a potential strategy to prevent or treat certain allergies. There are different mechanisms of action by which probiotics may exert their effects on the treatment or prevention of allergies through modulation of the immune system and stimulation of tolerance. Probiotics promote a change in IM. In addition, probiotics stimulate gut-associated lymphoid tissue, modulating inflammation and immune reactions present in AR, promoting a more favourable profile by increasing the production of the modulatory cytokines IL-10 and TGFβ by Treg cells. Probiotics can restore the Th1:Th2 balance by inducing Th1 responses through the production of IL-12 and interferon (IFN)-γ, or by suppressing Th2 responses through the depletion of IL-4. In addition, probiotics may exert immunomodulatory effects through stimulating mucosal IgA production. The hypothesis of the present study is that supplementation with the probiotic Bifidobacterium longum ES1 and/or with the heat treated version of ES1 will decrease the symptomatology associated with AR and improve the quality of life of individuals by modulating IM and potentiating Treg cells and the Th1 response. The main objective of the present study is to determine the effects of supplementation with the probiotic Bifidobacterium longum ES1 and the heat treated version of ES1 (HT-ES1) on the symptoms associated with AR. The secondary objectives of the study are to determine the effects of the treatments over: 1) Quality of life; 2) Blood immunological markers (IFN-γ, IL-12, IL-10, TGF-β, IgE, IL-4, IL-13, IL-19 and IL-8); 3) Faecal immunological marker IgA; 4)Faecal microbiota composition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
CollaboratorsADM-BIOPOLIS S.L.

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 26, 2022
Enrollment StartJan 23, 2022
Primary CompletionJan 17, 2024
Study CompletionMar 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.4 years ago

Interventions

ES1 groupdietary

Participants will intake 2 capsules of Bifidobacterium longum ES1 (2E09 CFU of probiotic/day with maltodextrin as excipient).

HT-ES1 groupdietary

Participants will intake 2 capsules of HT-ES1 (2E09 cells/day equivalent to 20 mg/day when prepared from a postbiotic batch at a concentration of 1E11 cells/g with maltodextrin as excipient).

Control groupdietary

Participants will intake 2 capsules/day, with 250 mg maltodextrin/capsule.