Allergic Rhinitis (AR)NCT06699537
Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis
A study testing probiotic product and Maltodextrin in people with Allergic Rhinitis (AR), run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis symptoms and its effects on gut microbiota in 70 adults aged 18-60 years. Participants will receive probiotic powder or placebo daily for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis (AR)
- What is being tested?
- probiotic product and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 May 2026
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study;
- Capable of completing the study according to the test protocol requirements;
- Age between 18 to 60 years old;
- Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)";
- Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than one hour per day, possibly accompanied by eye itching, tearing, and redness, and other ocular symptoms;
- Signs: Nasal mucosa is pale and edematous, possibly with watery secretions;
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- Laboratory tests: At least one allergen detected by skin prick test and/or specific IgE positivity in serum;
- No use of antihistamines, corticosteroids, or immunosuppressants in the month before screening;
- No history of heart, liver, kidney, nervous system, mental disorders, or metabolic abnormalities.
Who cannot join
- Use of medications affecting the gut microbiota (including antimicrobial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening;
- Patients with coexisting pulmonary tuberculosis;
- Those with coexisting allergic asthma;
- Individuals with nasal polyps or severe nasal septal deviation;
- Patients with severe systemic diseases or malignant tumors;
- Those with congenital genetic diseases or congenital immunodeficiency diseases;
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- Regular use of probiotics or prebiotics within 6 months prior to the screening period;
- Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);
- Those with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
- Individuals with sinusitis, otitis media, or respiratory tract infections;
- Those allergic to any components of the probiotics used in this trial;
- Women who are pregnant or breastfeeding, or those planning to conceive in the near future;
- Subjects who discontinue the test sample or add other medications midway, making it impossible to determine efficacy or with incomplete information;
- Those who have recently consumed items similar to the test product, affecting the judgment of the results;
- Subjects who, due to their own reasons, cannot participate in the trial;
- Any other subjects deemed unsuitable to participate by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Lacticaseibacillus Rhamnosus LRa05 in Alleviating Allergic Rhinitis and Its Impact on Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial
This clinical trial aims to evaluate the efficacy and safety of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis symptoms and its effects on gut microbiota in 70 adults aged 18-60 years. Participants will receive probiotic powder or placebo daily for 4 weeks. Allergic rhinitis symptoms and quality of life will be assessed, while stool and blood samples will be collected to evaluate changes in gut microbiota and immune-related markers.
- Conditions
- Allergic Rhinitis (AR)
- Being tested
- probiotic product, Maltodextrin
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic productDietary supplement
During the study, subjects take one sachet of Lactobacillus rhamnosus LRa05 daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the intervention.
MaltodextrinDietary supplement
During the study, subjects in the control group take one sachet of maltodextrin daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the 8-week trial.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Participants in the probiotic group received 1 sachet probiotic product per day. Receives: Dietary Supplement: probiotic product |
| Placebo group | Placebo comparator | Participants in the placebo group received 3g of maltodextrin per day. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score (TNSS)
The TNSS assesses four nasal symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe), with a total score ranging from 0 to 12. Higher scores indicate greater symptom severity.
Measured: 4 weeks
Change in Total Non-Nasal Symptom Score (TNNSS) from Baseline
The TNNSS assesses five associated symptoms: postnasal drip, tearing, nasal or ocular itching, nasal or oral maxillary pain, and headache. Each symptom is assessed based on its presence or absence.
Measured: 4 weeks
Change in Serum Allergen-Specific IgE Levels
Serum allergen-specific IgE levels will be measured to evaluate changes in allergic sensitization following the intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Nov 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis (AR)Studies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699537
- Sponsor's protocol ID
- WK2024016
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lacticaseibacillus Rhamnosus LRa05 in Alleviating Allergic Rhinitis and Its Impact on Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06699537
- Acronym / sponsor ID
- WK2024016
- Conditions
- Allergic Rhinitis (AR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 21 Nov 2024 (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.
This clinical trial aims to evaluate the efficacy and safety of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis symptoms and its effects on gut microbiota in 70 adults aged 18-60 years. Participants will receive probiotic powder or placebo daily for 4 weeks. Allergic rhinitis symptoms and quality of life will be assessed, while stool and blood samples will be collected to evaluate changes in gut microbiota and immune-related markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: probiotic productParticipants in the probiotic group received 1 sachet probiotic product per day. |
| Placebo group | Placebo comparator | Dietary Supplement: MaltodextrinParticipants in the placebo group received 3g of maltodextrin per day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study;
- Capable of completing the study according to the test protocol requirements;
- Age between 18 to 60 years old;
- Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)";
- Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than one hour per day, possibly accompanied by eye itching, tearing, and redness, and other ocular symptoms;
Key exclusion criteria (16 listed)
- Use of medications affecting the gut microbiota (including antimicrobial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening;
- Patients with coexisting pulmonary tuberculosis;
- Those with coexisting allergic asthma;
- Individuals with nasal polyps or severe nasal septal deviation;
- Patients with severe systemic diseases or malignant tumors;
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 |
|---|---|---|
| probiotic productDuring the study, subjects take one sachet of Lactobacillus rhamnosus LRa05 daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the intervention. | Dietary supplement | Probiotic group |
| MaltodextrinDuring the study, subjects in the control group take one sachet of maltodextrin daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the 8-week trial. | Dietary supplement | Placebo group |
Primary outcome
Change in Total Nasal Symptom Score (TNSS)
Time frame: 4 weeks
The TNSS assesses four nasal symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe), with a total score ranging from 0 to 12. Higher scores indicate greater symptom severity.
Change in Total Non-Nasal Symptom Score (TNNSS) from Baseline
Time frame: 4 weeks
The TNNSS assesses five associated symptoms: postnasal drip, tearing, nasal or ocular itching, nasal or oral maxillary pain, and headache. Each symptom is assessed based on its presence or absence.
Change in Serum Allergen-Specific IgE Levels
Time frame: 4 weeks
Serum allergen-specific IgE levels will be measured to evaluate changes in allergic sensitization following the intervention.
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 19 Oct 2026.
- Individual participant dataSharing planned: No
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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 probiotic product and Maltodextrin in people with Allergic Rhinitis (AR), run by Wecare Probiotics Co., Ltd. at 1 site in China.
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 16 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 19 Oct 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 China. 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?
Change in Total Nasal Symptom Score (TNSS) (time frame: 4 weeks). The study lists 3 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 19 Oct 2026.