Children With Allergic RhinitisNCT06885632
Effectiveness of Probiotic Gummies 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 effect of probiotic gummies on symptoms of allergic rhinitis, immune-inflammatory factors, and host metabolism in children with allergic rhinitis compared with placebo. 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
- 52 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 20 Aug 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
- (1) voluntary participation with written informed consent obtained prior to study enrollment; (2) ability to comply with the study procedures in accordance with the trial protocol; (3) age between 4 and 14 years, inclusive; (4) meeting the diagnostic criteria for AR as outlined in the Guidelines for the Diagnosis and Treatment of Pediatric AR (2022 Revised Edition); (5) presence of at least two of the following symptoms: sneezing, watery rhinorrhea, nasal itching, or nasal congestion, with a total daily symptom duration exceeding one hour, either continuously or cumulatively, and potentially accompanied by ocular manifestations such as ocular itching, tearing, or conjunctival hyperemia; (6) clinical signs including pale and edematous nasal mucosa, with or without watery nasal discharge.
Who cannot join
- use of medications affecting intestinal flora (e.g., antibacterial drugs, microecological agents, intestinal mucosa protectants, Chinese patent medicines) for more than one continuous week within one month prior to screening;
- patients with pulmonary tuberculosis;
- patients with allergic asthma;
- patients with nasal polyps or severe nasal septum deviation;
- patients with severe systemic diseases or malignant tumors;
- patients with congenital genetic diseases or congenital immune deficiency diseases;
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- patients who have regularly used probiotics or prebiotics within 6 months prior to screening;
- patients with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
- patients with metabolic syndrome symptoms (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
- patients with sinusitis, otitis media, or respiratory tract infections;
- patients who are allergic to the components of the probiotics used in this trial;
- patients who have stopped taking the test sample or have taken other drugs midway, making it impossible to determine efficacy or having incomplete data;
- patients whose recent use of substances with functions similar to the test sample could interfere with the accurate judgment of the trial results;
- subjects who are unable to participate in the trial due to their own reasons; (15) other subjects deemed ineligible for participation by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, 471000
About this study
Official title: Weizmannia Coagulans BC99 Gummy Alleviates Pediatric Allergic Rhinitis Via Modulating Gut Metabolism
To evaluate the effect of probiotic gummies on symptoms of allergic rhinitis, immune-inflammatory factors, and host metabolism in children with allergic rhinitis compared with placebo.
- 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 8 weeks and each patient will have 3 visits (week0, week4, week8).
PlaceboDietary supplement
The experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99 Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | No probiotic pectin gummies/2 pellets/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes allergic rhinitis symptoms before and after the intervention.
The assessment was done using three scales: VAS (Visual Analog Scale), TNSS (Total Nasal Symptom Score), and TTNNSS (Total Nasal and Non-Nasal Symptom Score). VAS quantifies overall symptom severity on a 0-10 visual scale (0 = no symptoms, 10 = extremely severe), with higher scores indicating a heavier symptom burden. TNSS uses a 0-3 scale to semi-quantitatively evaluate four core nasal symptoms, with each symptom scored from 0 to 3, giving a total score range of 0-12. TNNSS uses a 0-3 scoring system to semi-quantitatively analyze non-nasal symptoms, with a total score range of 0-15. For all three scales, higher scores indicate more severe symptoms.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Oct 2024
- Primary completion15 May 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 52 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
- NCT06885632
- Sponsor's protocol ID
- WK20250314
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weizmannia Coagulans BC99 Gummy Alleviates Pediatric Allergic Rhinitis Via Modulating Gut Metabolism
- ClinicalTrials.gov ID
- NCT06885632
- Acronym / sponsor ID
- WK20250314
- Conditions
- Children With Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 20 Mar 2025 (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 effect of probiotic gummies on symptoms of allergic rhinitis, immune-inflammatory factors, and host metabolism in children with allergic rhinitis compared with placebo.
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 |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboNo probiotic pectin gummies/2 pellets/day |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (1) voluntary participation with written informed consent obtained prior to study enrollment; (2) ability to comply with the study procedures in accordance with the trial protocol; (3) age between 4 and 14 years, inclusive; (4) meeting the diagnostic criteria for AR as outlined in the Guidelines for the Diagnosis and Treatment of Pediatric AR (2022 Revised Edition); (5) presence of at least two of the following symptoms: sneezing, watery rhinorrhea, nasal itching, or nasal congestion, with a total daily symptom duration exceeding one hour, either continuously or cumulatively, and potentially accompanied by ocular manifestations such as ocular itching, tearing, or conjunctival hyperemia; (6) clinical signs including pale and edematous nasal mucosa, with or without watery nasal discharge.
Key exclusion criteria (14 listed)
- use of medications affecting intestinal flora (e.g., antibacterial drugs, microecological agents, intestinal mucosa protectants, Chinese patent medicines) for more than one continuous week within one month prior to screening;
- patients with pulmonary tuberculosis;
- patients with allergic asthma;
- patients with nasal polyps or severe nasal septum 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 |
|---|---|---|
| ProbioticThe experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8). | Dietary supplement | Probiotic group |
| PlaceboThe experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8). | Dietary supplement | Placebo group |
Primary outcome
Changes allergic rhinitis symptoms before and after the intervention.
Time frame: Week 0 and Week 8
The assessment was done using three scales: VAS (Visual Analog Scale), TNSS (Total Nasal Symptom Score), and TTNNSS (Total Nasal and Non-Nasal Symptom Score). VAS quantifies overall symptom severity on a 0-10 visual scale (0 = no symptoms, 10 = extremely severe), with higher scores indicating a heavier symptom burden. TNSS uses a 0-3 scale to semi-quantitatively evaluate four core nasal symptoms, with each symptom scored from 0 to 3, giving a total score range of 0-12. TNNSS uses a 0-3 scoring system to semi-quantitatively analyze non-nasal symptoms, with a total score range of 0-15. For all three scales, higher scores indicate more severe symptoms.
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 17 Jun 2026.
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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 1 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 17 Jun 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?
Changes allergic rhinitis symptoms before and after the intervention. (time frame: Week 0 and Week 8). 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 17 Jun 2026.