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Can a probiotic tame hay fever? new study investigates

NCT ID NCT05208528

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested whether a probiotic called Bifidobacterium longum ES1, or its heat-treated version, could reduce symptoms of allergic rhinitis (hay fever) in 72 adults with moderate-to-severe dust mite allergies. Participants took daily capsules for several weeks and reported their symptoms and medication use. The goal was to see if these supplements could improve quality of life and reduce the need for rescue medicines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bifidobacterium longum ES1 (a probiotic) and its heat-treated form (HT-ES1)
What this could lead to
If it works, this could point toward a natural supplement to help manage allergic rhinitis symptoms and reduce reliance on medication.
What could go wrong
This is a small, early-stage trial with only 72 participants. The effects may be modest or not better than a placebo, and results may not apply to everyone with allergies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

72 people

The number who actually took part.

Started

Jan 2022

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

allergic rhinitis Inflammation Rhinitis, Allergic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Eurecat

    Reus, Reus, 43204, Spain

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Other studies related to the condition(s) this trial covers.