Allergic RhinitisMICRORIN_2NCT05208528
Effect of the Probiotic ES1 and Its Inactivated Form (HT-ES1) Over Symptomatology Asociated With Allergic Rhinitis
A study testing ES1 group and HT-ES1 group in people with Allergic Rhinitis, run by Fundació Eurecat at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ES1 group and HT-ES1 group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2022to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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 symptoms and dust mite allergy.
The 75 study participants will be randomly divided into three groups depending on whether they receive supplementation with the probiotic Bifidobacterium longum ES1, supplementation with the heat treated version of ES1 (HT-ES1) or placebo during the 2-month study period. After the treatment period the volunteers will be followed up for one month.
During the study, patients will be able to continue using conventional drug treatment for AR, including oral and local antihistamines, oral and intranasal corticosteroids, and intranasal decongestants.
Intervention products are the probiotic Bifidobacterium longum ES1 (ES1), the heat treated version of ES1 (HT-ES1) and a placebo (maltodextrin). The delivery format of the products to the volunteers will be in capsules.
The total duration of the study will be of 92 days (13 weeks).
Each participant will perform 4 visits. The study visits will be the following:
- a pre-selection visit to check inclusion/exclusion criteria (V0; day 1, week 1) and, in case of meeting the criteria,
- a study start visit (V1; day 8 +/-3 days; week 2),
- a final study visit (V2; day 64 +/- 3 days; week 10),
- a study follow-up visit (V3; day 92 +/- 3 days; week 14).
At visits V0, V1, V2 and V3 the use of any medications, including over the counter, will be checked.
In visits V1, V2 participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, in visits V2 and V3, participants will be asked for the presence of adverse events that could be associated with the consumption or withdrawal of the study products.
The products will be given in the V1 visit so that the participants will have all the necessary treatment to carry out the 8 weeks of study with the corresponding product.
During the study and starting from visit V0 once the volunteer has been included in the study and signed the informed consent, participants will record AR symptomatology and/or the use of AR medication on a daily basis by using the CSMS questionnaire described by Pfaar O. et al. in an online format using the Microsoft Forms application. During the study, the research team will monitor compliance of the online questionnaire by the volunteer.
Volunteers will be encouraged to maintain their dietary habits and to maintain their regular practice of physical activity during the study.
Descriptive variables related to AR and demographic variables will be obtained from participants of the study by clinical history and interviewing at visit V0.
In visits V1, V2 and V3 of the study, health-related quality of life data will be obtained by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) according to Juniper, E, et al.
For the collection of faeces in visits V1, V2 and V3, participants will be previously provided with a faeces collection kit (two different labelled tubes, one for metagenomic analysis and other for IgA determination will be provided).
- Conditions
- Allergic Rhinitis
- Being tested
- ES1 group, HT-ES1 group, Control group
- Keywords
- Probiotics, Intestinal Microbiota, Immune system, Inflammation, Postbiotics
- Medical subject headings
- Rhinitis, Allergic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES1 groupDietary supplement
Participants will intake 2 capsules of Bifidobacterium longum ES1 (2E09 CFU of probiotic/day with maltodextrin as excipient).
HT-ES1 groupDietary 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).
Control groupDietary supplement
Participants will intake 2 capsules/day, with 250 mg maltodextrin/capsule.
| Study group | Role | What they receive |
|---|---|---|
| ES1 group | Experimental | Participants treated with Bifidobacterium longum ES1 for 2 months. Receives: Dietary Supplement: ES1 group |
| HT-ES1 group | Experimental | Participants treated with heat treated version of ES1 for 2 months. Receives: Dietary Supplement: HT-ES1 group |
| Control group | Placebo comparator | Participants treated with maltodextrin for 2 months. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily for the thirteen weeks of the study.
Secondary outcomes (18)
Nasal and conjunctival symptoms (dSS)
The CSMS is the sum of the daily symptom score (dSS) and the daily medication score (dMS). The dSS is composed of 6 individual symptom scores: 4 nasal symptoms and 2 ocular symptoms, all rated on a scale of 0 to 3. The dSS is calculated as the mean of all daily dSS (range 0-18) and divided by the number of individual symptoms (6 symptoms). Therefore, the mean dSS can range from 0 to 3. The mean dSS 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.
Measured: Daily for the thirteen weeks of the study.
Nasal symptoms.
4 nasal symptoms: itchy nose, sneezing, runny nose and stuffy nose. All nasal symptoms rated on a scale of 0 to 3. The Nasal symptoms is calculated as the mean of all daily nasal symptoms (range 0-12) and divided by the number of individual nasal symptoms (4 symptoms). Therefore, the mean Nasal symptoms can range from 0 to 3, being higher scores related to worse symptoms. The mean Nasal symptoms 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.
Measured: Daily for the thirteen weeks of the study.
Conjunctival symptoms
2 ocular symptoms: itchy/red eyes and watery eyes. All conjunctival symptoms rated on a scale of 0 to 3. The conjunctival symptoms is calculated as the mean of all daily conjunctival symptoms (range 0-6) and divided by the number of individual conjunctival symptoms (2 symptoms). Therefore, the mean conjunctival symptoms can range from 0 to 3, being higher scores related to worse symptoms. The mean conjunctival symptoms 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.
Measured: Daily for the thirteen weeks of the study.
Use of rescue medication.
The daily medication score (dMS) is based on the following scores: 0, no rescue medication; 1, oral and/or topical nonsedative H1 antihistamines (H1A); 2, Intranasal corticosteroids (INS) with/without H1A; and 3, oral corticosteroids with/without INS, with/without H1A.
Measured: Daily for the thirteen weeks of the study.
Number of days without medication.
From CSMS questionnaire the number of days without rescue medication is quantified for each period of the study.
Measured: Daily for the thirteen weeks of the study.
Use of other medications for AR.
Participants will record daily the use of other treatments for AR different that the medications described in the CSMS questionnaire using the online questionnaire.
Measured: Daily for the thirteen weeks of the study.
Change in experienced troublesome functional impairments.
Quality of life will be estimated through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The RQLQ is a validated questionnaire which has 28 questions in seven domains (sleep, non-rhinoconjunctivitis symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional function). Patients are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0 = no impairment; 6 = maximum impairment). The overall RQLQ score is the mean of all 28 responses and higher scores reflect lower quality of life.
Measured: At week 2, week 10 and week 14.
Change in serum IL-10 levels.
Serum IL-10 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum TGF-β levels.
Serum TGF-β levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IL-12 levels.
Serum IL-12 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IFN-γ levels.
Serum IFN-γ levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IgE levels.
Serum IgE levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IL-4 levels.
Serum IL-4 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IL-13 levels.
Serum IL-13 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IL-8 levels.
Serum IL-8 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in serum IL-19 levels.
Serum IL-19 levels will be measured by human ELISA kits.
Measured: At week 2 and week 10.
Change in stool IgA levels.
Stool IL-19 levels will be measured by human ELISA kits.
Measured: At week 2, week 10 and week 14.
Metagenomic analysis.
Total DNA extracted from stool samples will be sequenced on an Illumina platform. It will be analysed the taxonomic profile, toxin-producing genes, bacterial functions and presence of pathogens.
Measured: At week 2, week 10 and week 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start23 Jan 2022
- Primary completion17 Jan 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- ADM-BIOPOLIS S.L.
- Responsible party
- Sponsor
- Investigators
- Josep M Del Bas, PhD, Principal investigator, UTNS (Eurecat-Reus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208528
- Sponsor's protocol ID
- MICRORIN_2
- Acronym
- MICRORIN_2
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2022
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42047238
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05208528
- Acronym / sponsor ID
- MICRORIN_2 / MICRORIN_2
- Conditions
- Allergic Rhinitis
- Keywords
- Probiotics, Intestinal Microbiota, Immune system, Inflammation, Postbiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- ADM-BIOPOLIS S.L.
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 symptoms and dust mite allergy.
The 75 study participants will be randomly divided into three groups depending on whether they receive supplementation with the probiotic Bifidobacterium longum ES1, supplementation with the heat treated version of ES1 (HT-ES1) or placebo during the 2-month study period. After the treatment period the volunteers will be followed up for one month.
During the study, patients will be able to continue using conventional drug treatment for AR, including oral and local antihistamines, oral and intranasal corticosteroids, and intranasal decongestants.
Intervention products are the probiotic Bifidobacterium longum ES1 (ES1), the heat treated version of ES1 (HT-ES1) and a placebo (maltodextrin). The delivery format of the products to the volunteers will be in capsules.
The total duration of the study will be of 92 days (13 weeks).
Each participant will perform 4 visits. The study visits will be the following:
- a pre-selection visit to check inclusion/exclusion criteria (V0; day 1, week 1) and, in case of meeting the criteria,
- a study start visit (V1; day 8 +/-3 days; week 2),
- a final study visit (V2; day 64 +/- 3 days; week 10),
- a study follow-up visit (V3; day 92 +/- 3 days; week 14).
At visits V0, V1, V2 and V3 the use of any medications, including over the counter, will be checked.
In visits V1, V2 participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, in visits V2 and V3, participants will be asked for the presence of adverse events that could be associated with the consumption or withdrawal of the study products.
The products will be given in the V1 visit so that the participants will have all the necessary treatment to carry out the 8 weeks of study with the corresponding product.
During the study and starting from visit V0 once the volunteer has been included in the study and signed the informed consent, participants will record AR symptomatology and/or the use of AR medication on a daily basis by using the CSMS questionnaire described by Pfaar O. et al. in an online format using the Microsoft Forms application. During the study, the research team will monitor compliance of the online questionnaire by the volunteer.
Volunteers will be encouraged to maintain their dietary habits and to maintain their regular practice of physical activity during the study.
Descriptive variables related to AR and demographic variables will be obtained from participants of the study by clinical history and interviewing at visit V0.
In visits V1, V2 and V3 of the study, health-related quality of life data will be obtained by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) according to Juniper, E, et al.
For the collection of faeces in visits V1, V2 and V3, participants will be previously provided with a faeces collection kit (two different labelled tubes, one for metagenomic analysis and other for IgA determination will be provided).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ES1 group | Experimental | Dietary Supplement: ES1 groupParticipants treated with Bifidobacterium longum ES1 for 2 months. |
| HT-ES1 group | Experimental | Dietary Supplement: HT-ES1 groupParticipants treated with heat treated version of ES1 for 2 months. |
| Control group | Placebo comparator | Dietary Supplement: Control groupParticipants treated with maltodextrin for 2 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- Present the criteria for moderate-to-severe persistent AR phenotype according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES1 groupParticipants will intake 2 capsules of Bifidobacterium longum ES1 (2E09 CFU of probiotic/day with maltodextrin as excipient). | Dietary supplement | ES1 group |
| HT-ES1 groupParticipants 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 | HT-ES1 group |
| Control groupParticipants will intake 2 capsules/day, with 250 mg maltodextrin/capsule. | Dietary supplement | Control group |
Primary outcome
Combined Symptoms and Medication Score
Time frame: Daily for the thirteen weeks of the study.
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.
18 secondary outcomes
Nasal and conjunctival symptoms (dSS)
Time frame: Daily for the thirteen weeks of the study.
Nasal symptoms.
Time frame: Daily for the thirteen weeks of the study.
Conjunctival symptoms
Time frame: Daily for the thirteen weeks of the study.
Use of rescue medication.
Time frame: Daily for the thirteen weeks of the study.
Number of days without medication.
Time frame: Daily for the thirteen weeks of the study.
Use of other medications for AR.
Time frame: Daily for the thirteen weeks of the study.
Change in experienced troublesome functional impairments.
Time frame: At week 2, week 10 and week 14.
Change in serum IL-10 levels.
Time frame: At week 2 and week 10.
Change in serum TGF-β levels.
Time frame: At week 2 and week 10.
Change in serum IL-12 levels.
Time frame: At week 2 and week 10.
Change in serum IFN-γ levels.
Time frame: At week 2 and week 10.
Change in serum IgE levels.
Time frame: At week 2 and week 10.
Change in serum IL-4 levels.
Time frame: At week 2 and week 10.
Change in serum IL-13 levels.
Time frame: At week 2 and week 10.
Change in serum IL-8 levels.
Time frame: At week 2 and week 10.
Change in serum IL-19 levels.
Time frame: At week 2 and week 10.
Change in stool IgA levels.
Time frame: At week 2, week 10 and week 14.
Metagenomic analysis.
Time frame: At week 2, week 10 and week 14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 42047238Cardoso 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.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M Del Bas, PhD principal investigator
UTNS (Eurecat-Reus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES1 group and HT-ES1 group in people with Allergic Rhinitis, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Symptoms and Medication Score (time frame: Daily for the thirteen weeks of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.