Children With Allergic RhinitisNCT06676111
Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children
A study testing Probiotic in people with Children With Allergic Rhinitis, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Children With Allergic Rhinitis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 31 Jul 2025
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary, written, and signed informed consent form, agreeing to participate in this study;
- Capable of completing research according to the requirements of the experimental plan;
- Age range: 4-14 years old;
- Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
- Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, tearing, and redness;
- Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.
Who cannot join
- Drugs that affect the intestinal flora (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening;
- Merge with tuberculosis patients;
- Combined with allergic asthma;
- Patients with nasal polyps or severe nasal septum deviation;
- Patients with serious systemic diseases or malignant tumors;
- Individuals with congenital genetic disorders or congenital immunodeficiency diseases;
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- Regular use of probiotics or prebiotics within the first 6 months of the screening period;
- Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.);
- Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
- Patients with combined sinusitis, otitis media, or respiratory infections;
- Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data;
- Short term use of substances with similar functions to the test subject affects the judgment of the results;
- The subject is unable to participate in the trial due to personal reasons;
- Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.
- Conditions
- Children With Allergic Rhinitis
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)
PlaceboDietary supplement
The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Score 0 - asymptomatic; Score 1 - mild symptoms, easily tolerated; Score 2 - moderate symptoms, annoying but tolerable; Score 3 - Severe symptoms, intolerable, affecting daily life and sleep. Add them together to get the total score
Measured: 56 days
Visual Analogue Scale (VAS)
"0" means no such symptoms; "10" means that this symptom is the most severe. Add them together to get the total score
Measured: 56 days
Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)
0 points: no trouble; 1 point: little to no distress; 2 points: occasional distress; Score 3: Moderate degree of distress; 4: Somewhat bothered, 5: Very bothered; Score 6: Extremely distressed
Measured: 56 days
Medication scores
Scoring drugs include oral antihistamines (3 points/tablet, maximum 6 points), oral leukotriene receptor antagonists (2 points/dose), nasal glucocorticoids (1 point/spray, maximum 8 points), nasal spray or eye drops antihistamines (0.5 points/spray or drop, maximum 4 points), and the daily average score for the past 1 week was calculated.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Oct 2024
- Primary completion10 Feb 2025
- Study completion31 Jul 2025
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 Children With Allergic RhinitisStudies 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
- 72 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
- NCT06676111
- Sponsor's protocol ID
- WK2024009
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han Z, Zhu H, Yang Y, Wang Y, Li X, Zhu J, Wu Y, Fang S, Gu S. Weizmannia coagulans BC99 alleviates pediatric allergic rhinitis via the gut microbiota-SCFAs- immunomodulatory axis: A randomized, double-blind, placebo-controlled trial. Int Immunopharmacol. 2026 Jan 1;168(Pt 1):115787. doi: 10.1016/j.intimp.2025.115787. Epub 2025 Nov 5.
PubMed 41197269
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile
- ClinicalTrials.gov ID
- NCT06676111
- Acronym / sponsor ID
- WK2024009
- Conditions
- Children With Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 6 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.
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.
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: ProbioticProbiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboNo probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Voluntary, written, and signed informed consent form, agreeing to participate in this study;
- Capable of completing research according to the requirements of the experimental plan;
- Age range: 4-14 years old;
- Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
- Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, tearing, and redness;
Key exclusion criteria (14 listed)
- Drugs that affect the intestinal flora (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening;
- Merge with tuberculosis patients;
- Combined with allergic asthma;
- Patients with nasal polyps or severe nasal septum deviation;
- Patients with serious 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 |
|---|---|---|
| ProbioticThe experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8) | Dietary supplement | Probiotic group |
| PlaceboThe experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8) | Dietary supplement | Placebo group |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: 56 days
Score 0 - asymptomatic; Score 1 - mild symptoms, easily tolerated; Score 2 - moderate symptoms, annoying but tolerable; Score 3 - Severe symptoms, intolerable, affecting daily life and sleep. Add them together to get the total score
Visual Analogue Scale (VAS)
Time frame: 56 days
"0" means no such symptoms; "10" means that this symptom is the most severe. Add them together to get the total score
Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)
Time frame: 56 days
0 points: no trouble; 1 point: little to no distress; 2 points: occasional distress; Score 3: Moderate degree of distress; 4: Somewhat bothered, 5: Very bothered; Score 6: Extremely distressed
Medication scores
Time frame: 56 days
Scoring drugs include oral antihistamines (3 points/tablet, maximum 6 points), oral leukotriene receptor antagonists (2 points/dose), nasal glucocorticoids (1 point/spray, maximum 8 points), nasal spray or eye drops antihistamines (0.5 points/spray or drop, maximum 4 points), and the daily average score for the past 1 week was calculated.
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 6 Oct 2025.
- Derived from this study: PubMed 41197269Han Z, Zhu H, Yang Y, Wang Y, Li X, Zhu J, Wu Y, Fang S, Gu S. Weizmannia coagulans BC99 alleviates pediatric allergic rhinitis via the gut microbiota-SCFAs- immunomodulatory axis: A randomized, double-blind, placebo-controlled trial. Int Immunopharmacol. 2026 Jan 1;168(Pt 1):115787. doi: 10.1016/j.intimp.2025.115787. Epub 2025 Nov 5.
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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 in people with Children With Allergic Rhinitis, 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 6 inclusion and 14 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 6 Oct 2025. 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?
Total Nasal Symptom Score (TNSS) (time frame: 56 days). 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?
On the ClinicalTrials.gov record for NCT06676111, 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 6 Oct 2025.