Status:
COMPLETED
Effect of the Probiotic ES1 and Its Inactivated Form (HT-ES1) Over Symptomatology Asociated With Allergic Rhinitis
Lead Sponsor:
Fundació Eurecat
Collaborating Sponsors:
ADM-BIOPOLIS S.L.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Detailed Description
Parallel, randomized, placebo-controlled, and double-blind intervention trial. 75 participants (25 in each group), men and women, aged between 18 and 60 years, with moderate-severe persistent AR symp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- 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.
Key Trial Info
Start Date :
January 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05208528
Start Date
January 23 2022
End Date
March 27 2024
Last Update
October 31 2024
Active Locations (1)
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1
Eurecat
Reus, Spain, 43204