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NCT05208528

Effect of the Probiotic ES1 and Its Inactivated Form (HT-ES1) Over Symptomatology Asociated With Allergic Rhinitis

Sponsor: Fundació Eurecat

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-01-23

Completion Date

2024-03-27

Last Updated

2026-05-04

Healthy Volunteers

Conditions

Allergic Rhinitis

Interventions

DIETARY_SUPPLEMENT

ES1 group

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

DIETARY_SUPPLEMENT

HT-ES1 group

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).

DIETARY_SUPPLEMENT

Control group

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

Inclusion Criteria: 1. Men and women between 18 and 60 years of age. 2. Present a medical history of ARs defined according to the International Consensus on Rhinitis for at least 2 years. 3. Present a positive IgE sensitization test to dust mite allergen during the last 5 years. \* Participants may present various sensitizations to different allergen in addition to allergy to dust mite. 4. Present the criteria for moderate-to-severe persistent AR phenotype according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification: * The intensity of signs and symptoms interferes with sleep; interferes with daily activities, sports and leisure; interferes with work activities; and symptoms present are troublesome. * The symptoms are present more than 4 days a week and during more than 4 consecutive weeks. 5. Present symptomatology at the pre-selection visit. This is, present, according to ARIA criteria, 2 or more of the following symptoms during more than 1 hour a day: water rhinorrhoea; sneezing, especially paroxysmal; nasal obstruction; nasal puritis; with or without conjunctivitis. 6. Sign the informed consent form. Exclusion Criteria: 1. Age under 18 or over 60 years old. 2. Present intolerances and/or food allergies related to the products of the study. 3. Being pregnant or intending to become pregnant. 4. Be in breastfeeding period. 5. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. 6. Present some chronic gastrointestinal disease. 7. Clinical history of anemia. 8. Having received antibiotic treatment up to 30 days before the start of the study. 9. Having received immunotherapy treatment for dust mite allergen before the start of the study and during the study. 10. Having received immunotherapy treatment for allergens other than dust mites up to 30 days before the start of the study and during the study. 11. Taking probiotics, prebiotics and/or postbiotics up to 30 days before the start of the study and during the study. 12. Present any disease with immune system involvement (HIV, autoimmune disease, hepatitis, cancer, etc.). 13. Having received chemotherapy or other immunosuppressive therapy during the previous year. 14. Medical history of surgical procedures of nasal cavity and sinuses, recent surgery of gastrointestinal tract or bariatric surgery (ever). 15. Being unable to follow the study guidelines.

Locations (1)

Eurecat

Reus, Reus, Spain

Clinical Research Directory

Effect of the Probiotic ES1 and Its Inactivated Form (HT-ES1) Over Symptomatology Asociated With Allergic Rhinitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)