Allergic RhinitisNCT06680102
Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota
A study testing Probiotic and Maltodextrin in people with Allergic Rhinitis, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2024to 25 Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily and in writing, sign an informed consent form agreeing to participate in this study;
- Able to complete the study as required by the trial protocol;
- Age between 18 and 65 years old;
- Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)";
- Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with daily symptoms lasting or accumulating for more than 1 hour, which may be accompanied by eye itching, tearing, and redness of the eyes and other ocular symptoms;
- Signs: Pale and edematous nasal mucosa, which may be accompanied by watery secretions.
Who cannot join
- Use of drugs affecting the gut microbiota (including antimicrobial agents, 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;
- Patients with coexisting allergic asthma;
- Patients with nasal polyps or severe nasal septum deviation;
- Patients with severe systemic diseases or malignant tumors;
- Individuals 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;
- Patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);
- Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
- Patients with sinusitis, otitis media, or respiratory tract infections;
- Individuals allergic to any components of the probiotics used in this trial;
- Pregnant or lactating women or those planning to conceive in the near future;
- Those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data;
- Recent use of products similar to the test function, affecting the judgment of the results;
- Participants who cannot participate in the trial due to their own reasons;
- Other participants deemed ineligible by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Food and Bioengineering, Henan University of Science and Technology
Luoyang, Henan, 471000
About this study
Official title: The Effectiveness of Weizmannia Coagulans BC99 in Alleviating Allergic Rhinitis in Adults and Its Impact on the Gut Microbiota.
Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.
- Conditions
- Allergic Rhinitis
- Being tested
- Probiotic, 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.
ProbioticDietary supplement
The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.
MaltodextrinDietary supplement
The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Probiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily.
Storage method: Keep away from light, seal tightly, and store in a cool, dry place. Receives: Dietary Supplement: Probiotic |
| Placebo Group | Placebo comparator | Gummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day.
Storage method: Keep away from light, seal tightly, and store in a cool, dry place. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of rhinitis symptoms in participants
Improvement in Nasal symptoms was assessed using the Total Nasal Symptom Score(TNSS), which included four common nasal symptoms: itchiness, nasal congestion, sneezing, and runny nose. The four symptoms were scored using a "four-point scale", that is, according to the severity of each symptom from 0 to 3 points, that is, the higher the score, the more severe the symptoms, and the total score of the entire TNSS score is the sum of the four symptom scores, which ranges from 0 to 12 points.
Measured: 8 weeks
Secondary outcomes (3)
16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention
Changes in subjects' fecal microbiota, including abundance and proportion of beneficial bacteria, were assessed by 16S rRNA sequencing before and after probiotic intervention.
Measured: 8 weeks
Effect of probiotic intervention on immunoglobulin in subjects
The changes of Immunoglobulin A and Immunoglobulin E before and after intervention were detected by ELISA.
Measured: 8 weeks
Impact on Serum Inflammatory Cytokines
Levels of IL-4, IL-5, IL-10, IL-13.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start25 Nov 2024
- Primary completion25 Dec 2024
- Study completion25 Mar 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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 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
- NCT06680102
- Sponsor's protocol ID
- WK2024010
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Han Z, Wu K, Lin B, Azeem S, Jiang Y, Dong Y, Gai Z, Fang S, Wu Y, Gu S. Weizmannia coagulans BC99 regulates oxidative stress and serum metabolic pathways to improve allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Front Immunol. 2025 Oct 24;16:1654724. doi: 10.3389/fimmu.2025.1654724. eCollection 2025.
PubMed 41208993
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Weizmannia Coagulans BC99 in Alleviating Allergic Rhinitis in Adults and Its Impact on the Gut Microbiota.
- ClinicalTrials.gov ID
- NCT06680102
- Acronym / sponsor ID
- WK2024010
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 8 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.
Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: ProbioticProbiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily. Storage method: Keep away from light, seal tightly, and store in a cool, dry place. |
| Placebo Group | Placebo comparator | Dietary Supplement: MaltodextrinGummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day. Storage method: Keep away from light, seal tightly, and store in a cool, dry place. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily and in writing, sign an informed consent form agreeing to participate in this study;
- Able to complete the study as required by the trial protocol;
- Age between 18 and 65 years old;
- Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)";
- Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with daily symptoms lasting or accumulating for more than 1 hour, which may be accompanied by eye itching, tearing, and redness of the eyes and other ocular symptoms;
Key exclusion criteria (16 listed)
- Use of drugs affecting the gut microbiota (including antimicrobial agents, 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;
- Patients with coexisting 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 for 8 weeks, with each patient making three visits at weeks 1, 4, and 8. | Dietary supplement | Probiotic Group |
| MaltodextrinThe experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8. | Dietary supplement | Placebo Group |
Primary outcome
Improvement of rhinitis symptoms in participants
Time frame: 8 weeks
Improvement in Nasal symptoms was assessed using the Total Nasal Symptom Score(TNSS), which included four common nasal symptoms: itchiness, nasal congestion, sneezing, and runny nose. The four symptoms were scored using a "four-point scale", that is, according to the severity of each symptom from 0 to 3 points, that is, the higher the score, the more severe the symptoms, and the total score of the entire TNSS score is the sum of the four symptom scores, which ranges from 0 to 12 points.
3 secondary outcomes
16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention
Time frame: 8 weeks
Effect of probiotic intervention on immunoglobulin in subjects
Time frame: 8 weeks
Impact on Serum Inflammatory Cytokines
Time frame: 8 weeks
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 4 Jul 2025.
- Derived from this study: PubMed 41208993Li X, Han Z, Wu K, Lin B, Azeem S, Jiang Y, Dong Y, Gai Z, Fang S, Wu Y, Gu S. Weizmannia coagulans BC99 regulates oxidative stress and serum metabolic pathways to improve allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Front Immunol. 2025 Oct 24;16:1654724. doi: 10.3389/fimmu.2025.1654724. eCollection 2025.
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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 and Maltodextrin in people 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 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 4 Jul 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?
Improvement of rhinitis symptoms in participants (time frame: 8 weeks). 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 NCT06680102, 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 4 Jul 2025.