Allergic RhinitisNCT07532837
The Effect of Oral Probiotics on Allergic Rhinitis Symptoms and the Quality of Life
A study testing Lactobacillus rhamnosus F-1 and Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 in people with Allergic Rhinitis, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
Allergic rhinitis (AR), also known as nasal allergy, hay fever or seasonal allergic rhinitis, is an inflammatory condition of the nasal passages caused by the immune system's response to allergens in the air. Symptoms include runny or blocked nose, nasal itching, sneezing, and red, itchy, and watery eyes. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Lactobacillus rhamnosus F-1 and Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Inclusion criteria:
- Age between 6 and 65 years.
- Diagnosed with allergic rhinitis by a qualified physician.
- Score ≥ 7 on the Score for Allergic Rhinitis (SFAR).
- Willing to participate and has signed the informed consent form.
- Exclusion criteria:
- History of drug allergy or use of medications with high sensitivity or contraindications (e.g., allergy to antibiotics or antipyretics).
- Patients with rhinitis symptoms caused by structural abnormalities such as a deviated nasal septum.
- Patients receiving oral corticosteroid therapy.
- Consumption of probiotic-related products within the past 1 month (including drops, tablets, capsules, powders, yogurt, or fermented milk containing live bacteria).
- Participation in other clinical studies within the past 1 month.
- Receipt of immunotherapy within the past 1 year.
- Presence of major illnesses (e.g., possession of a catastrophic illness certificate) or severe immune, hematological, or congenital disorders.
- Deemed unsuitable for participation by a physician.
Trial locations and contacts
1 site in 1 country.
About this study
Allergic rhinitis (AR), also known as nasal allergy, hay fever or seasonal allergic rhinitis, is an inflammatory condition of the nasal passages caused by the immune system's response to allergens in the air. Symptoms include runny or blocked nose, nasal itching, sneezing, and red, itchy, and watery eyes. These symptoms typically occur within minutes of exposure to allergens and can affect sleep, work productivity, and concentration during learning. Many patients with allergic rhinitis also suffer from conditions such as asthma, allergic conjunctivitis, or atopic dermatitis.Symptoms in the majority of patients tend to recur and persist over time. While medication can alleviate the symptoms, complete cure is challenging to achieve.
Probiotics are generally defined as microorganisms that, when ingested, provide beneficial effects to the host. They primarily consist of bacteria that produce lactic acid, including Lactobacilli, Bifidobacteria, and Saccharomyces boulardii. One known mechanism underlying allergic diseases is the overactivation of Th2 cells, leading to an imbalance in the Th1/Th2 ratio. Previous research has explored whether the use of probiotics can prevent allergic diseases. Numbers of studies indicate that probiotics have the ability to modulate the immune system by increasing anti-inflammatory cytokines such as IFN-γ, IL-10, and IL-12 to enhance Th1 cell activity. Simultaneously, they suppress pro-inflammatory cytokines like IL-4, IL-5, and IL-13, inhibiting excessive Th2 activation and restoring Th1/Th2 balance to improve symptoms.
Read more
Current evidence from clinical randomized controlled trials suggests that supplementation with probiotics during pregnancy and early infancy can prevent allergies or the development of more severe allergic conditions. However, regarding AR, current research has confirmed that probiotic consumption can improve the quality of life and the severity of nasal symptoms (measured by PRQLQ and TNSS) in AR patients. Nevertheless, the efficacy of regulating AR varies based on different strains or species of probiotics used.
This project aims to select probiotic strains that enhance the function of regulatory T cells (Treg cells), thereby promoting the secretion of Th1 cell cytokines IL-12 and IFN-γ to assist in achieving Th1/Th2 immune balance. This approach aims to reduce specific immunoglobulin E (IgE) levels and achieve an anti-inflammatory effect, thereby improving the regulation of allergic reactions within patients' bodies.
- Conditions
- Allergic Rhinitis
- Being tested
- Lactobacillus rhamnosus F-1, Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104, Placebo
- Keywords
- Allergic rhinitis, Probiotics, Intestinal Flora, Allergic Diseases
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus F-1Dietary supplement
Take one packet of probiotics (Lactobacillus rhamnosus F-1) twice daily.
Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104Dietary supplement
Take one packet of probiotics (Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104) twice daily.
PlaceboDietary supplement
Subjects take two capsules daily.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus rhamnosus F-1 | Experimental | Not described Receives: Dietary Supplement: Lactobacillus rhamnosus F-1 |
| Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 | Experimental | Not described Receives: Dietary Supplement: Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Score for Allergic Rhinitis(SFAR)
The score ranges from 0 to 16 and includes 8 items. A higher score indicates a more severe severity.
Measured: Baseline (pre-intervention).
Changes in blood biochemical inflammatory markers.
Changes in the levels of IgE, ECP, CBC, IL-4, IL-10, IL-12, IFN-γ, TGF-β, Vitamin D3, IL-17, and TNF-α.
Measured: Baseline (pre-intervention), after 12 weeks of probiotic supplementation。
Analysis of gut microbiota composition
Changes in gut microbiota ratios were assessed using NGS before and after the intervention.
Measured: Baseline (pre-intervention) and after 12 weeks of probiotic supplementation.
Changes in the Score for Allergic Rhinitis and Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ）
It includes 28 items across 7 areas (activity, sleep, non-nasal/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions). Using a 7-point scale (0 = no trouble, 6 = extreme trouble), the lower the score, the better the quality of life.
Measured: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Secondary outcomes (3)
Changes in Visual Analogue Scale(VAS) scores
The higher the number from 1 to 10, the more uncomfortable it feels.
Measured: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Changes in Total nasal symptoms score (TNSS).
It typically sums scores for four symptoms-nasal congestion, rhinorrhea (runny nose), nasal itching, and sneezing-each rated 0-3, resulting in a maximum total score of 12.A lower score indicates better control or improvement of nasal symptoms.
Measured: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Changes in Rhinitis Control Assessment Test (RCAT) scores
The questionnaire contains 6 items, with a total score range of 6-30 points. The lower the score, the worse the rhinitis control is usually.
Measured: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start26 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532837
- Sponsor's protocol ID
- CMUH112-REC1-161
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Probiotics on Allergic Rhinitis Symptoms and the Quality of Life
- ClinicalTrials.gov ID
- NCT07532837
- Acronym / sponsor ID
- CMUH112-REC1-161
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Probiotics, Intestinal Flora, Allergic Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2026 (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), also known as nasal allergy, hay fever or seasonal allergic rhinitis, is an inflammatory condition of the nasal passages caused by the immune system's response to allergens in the air. Symptoms include runny or blocked nose, nasal itching, sneezing, and red, itchy, and watery eyes. These symptoms typically occur within minutes of exposure to allergens and can affect sleep, work productivity, and concentration during learning. Many patients with allergic rhinitis also suffer from conditions such as asthma, allergic conjunctivitis, or atopic dermatitis.Symptoms in the majority of patients tend to recur and persist over time. While medication can alleviate the symptoms, complete cure is challenging to achieve.
Probiotics are generally defined as microorganisms that, when ingested, provide beneficial effects to the host. They primarily consist of bacteria that produce lactic acid, including Lactobacilli, Bifidobacteria, and Saccharomyces boulardii. One known mechanism underlying allergic diseases is the overactivation of Th2 cells, leading to an imbalance in the Th1/Th2 ratio. Previous research has explored whether the use of probiotics can prevent allergic diseases. Numbers of studies indicate that probiotics have the ability to modulate the immune system by increasing anti-inflammatory cytokines such as IFN-γ, IL-10, and IL-12 to enhance Th1 cell activity. Simultaneously, they suppress pro-inflammatory cytokines like IL-4, IL-5, and IL-13, inhibiting excessive Th2 activation and restoring Th1/Th2 balance to improve symptoms.
Current evidence from clinical randomized controlled trials suggests that supplementation with probiotics during pregnancy and early infancy can prevent allergies or the development of more severe allergic conditions. However, regarding AR, current research has confirmed that probiotic consumption can improve the quality of life and the severity of nasal symptoms (measured by PRQLQ and TNSS) in AR patients. Nevertheless, the efficacy of regulating AR varies based on different strains or species of probiotics used.
This project aims to select probiotic strains that enhance the function of regulatory T cells (Treg cells), thereby promoting the secretion of Th1 cell cytokines IL-12 and IFN-γ to assist in achieving Th1/Th2 immune balance. This approach aims to reduce specific immunoglobulin E (IgE) levels and achieve an anti-inflammatory effect, thereby improving the regulation of allergic reactions within patients' bodies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhamnosus F-1 | Experimental | Dietary Supplement: Lactobacillus rhamnosus F-1 |
| Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 | Experimental | Dietary Supplement: Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Lactobacillus rhamnosus F-1Take one packet of probiotics (Lactobacillus rhamnosus F-1) twice daily. | Dietary supplement | Lactobacillus rhamnosus F-1 |
| Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104Take one packet of probiotics (Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104) twice daily. | Dietary supplement | Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 |
| PlaceboSubjects take two capsules daily. | Dietary supplement | Placebo |
Primary outcome
Changes in Score for Allergic Rhinitis(SFAR)
Time frame: Baseline (pre-intervention).
The score ranges from 0 to 16 and includes 8 items. A higher score indicates a more severe severity.
Changes in blood biochemical inflammatory markers.
Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation。
Changes in the levels of IgE, ECP, CBC, IL-4, IL-10, IL-12, IFN-γ, TGF-β, Vitamin D3, IL-17, and TNF-α.
Analysis of gut microbiota composition
Time frame: Baseline (pre-intervention) and after 12 weeks of probiotic supplementation.
Changes in gut microbiota ratios were assessed using NGS before and after the intervention.
Changes in the Score for Allergic Rhinitis and Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ）
Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
It includes 28 items across 7 areas (activity, sleep, non-nasal/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions). Using a 7-point scale (0 = no trouble, 6 = extreme trouble), the lower the score, the better the quality of life.
3 secondary outcomes
Changes in Visual Analogue Scale(VAS) scores
Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Changes in Total nasal symptoms score (TNSS).
Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Changes in Rhinitis Control Assessment Test (RCAT) scores
Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus F-1 and Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104 in people with Allergic Rhinitis, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Score for Allergic Rhinitis(SFAR) (time frame: Baseline (pre-intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.