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

NCT05208528 | Completed

• 1 other identifier: MICRORIN_2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Keywords

Probiotics; Intestinal Microbiota; Immune system; Inflammation; Postbiotics

Outcome Measures

Primary Outcomes (1)

• Combined Symptoms and Medication Score

  Participants will complete the Combined Symptoms and Medication Score (CSMS) questionnaire daily in an online form. The CSMS questionnaire takes into account the severity of symptoms and the use of rescue medication to asses the efficacy of treatments for AR. The CSMS is the sum of daily symptom score (dSS) and the daily medication score (dMS) and has a range of 0 to 6. The mean CSMS will be calculated weekly for each study period, that is the basal period (first week until V1); the treatment period (period between V1 and V2 visits) and the follow-up period (period between V2 and V3 visits), from the sum of all daily CSMS during each week of the study and divided by the number of days of each week of the study.

  Daily for the thirteen weeks of the study.

Secondary Outcomes (18)

• Nasal and conjunctival symptoms (dSS)

  Daily for the thirteen weeks of the study.

• Nasal symptoms.

  Daily for the thirteen weeks of the study.

• Conjunctival symptoms

  Daily for the thirteen weeks of the study.

• Use of rescue medication.

  Daily for the thirteen weeks of the study.

• Number of days without medication.

  Daily for the thirteen weeks of the study.

Study Arms (3)

ES1 group

EXPERIMENTAL

Participants treated with Bifidobacterium longum ES1 for 2 months.

Dietary Supplement: ES1 group

HT-ES1 group

EXPERIMENTAL

Participants treated with heat treated version of ES1 for 2 months.

Dietary Supplement: HT-ES1 group

Control group

PLACEBO COMPARATOR

Participants treated with maltodextrin for 2 months.

Dietary Supplement: Control group

Interventions

ES1 group DIETARY_SUPPLEMENT

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

ES1 group

HT-ES1 group DIETARY_SUPPLEMENT

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).

HT-ES1 group

Control group DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 18 and 60 years of age.
• Present a medical history of ARs defined according to the International Consensus on Rhinitis for at least 2 years.
• 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.
• 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.
• 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.
• Sign the informed consent form.

You may not qualify if:

• Age under 18 or over 60 years old.
• Present intolerances and/or food allergies related to the products of the study.
• Being pregnant or intending to become pregnant.
• Be in breastfeeding period.
• Present some chronic gastrointestinal disease.
• Clinical history of anemia.
• Having received antibiotic treatment up to 30 days before the start of the study.
• Having received immunotherapy treatment for dust mite allergen before the start of the study and during the study.
• Having received immunotherapy treatment for allergens other than dust mites up to 30 days before the start of the study and during the study.
• Taking probiotics, prebiotics and/or postbiotics up to 30 days before the start of the study and during the study.
• Present any disease with immune system involvement (HIV, autoimmune disease, hepatitis, cancer, etc.).
• Having received chemotherapy or other immunosuppressive therapy during the previous year.
• Medical history of surgical procedures of nasal cavity and sinuses, recent surgery of gastrointestinal tract or bariatric surgery (ever).
• Being unable to follow the study guidelines.

Sponsors & Collaborators

• ADM-BIOPOLIS S.L.: collaborator
• Fundació Eurecat: lead

Study Sites (1)

Eurecat

Reus, Reus, 43204, Spain

Location

Related Publications (1)

• Cardoso A, Naghibi M, Climent E, Rodenes-Gavidia A, Lamelas A, Llobregat L, Martinez-Blanch J, Friedman D, Vijayakumar V, Day R. Effects of Live and Heat-Treated Bifidobacterium longum CECT 7347 in Adults With Allergic Rhinitis: A Randomised, Double-Blind, Placebo-Controlled Trial. Allergy. 2026 Apr 28. doi: 10.1111/all.70360. Online ahead of print.

  PMID: 42047238 DERIVED

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Conditions

Rhinitis, Allergic; Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Josep M Del Bas, PhD

  UTNS (Eurecat-Reus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: January 23, 2022
• Primary Completion: January 17, 2024
• Study Completion: March 27, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)