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CompletedNCT06676111Updated Oct 6, 2025

Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

An interventional study of Probiotic and Placebo in Children With Allergic Rhinitis, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
4 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Children With Allergic Rhinitis
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntary, written, and signed informed consent form, agreeing to participate in this study;
  2. Capable of completing research according to the requirements of the experimental plan;
  3. Age range: 4-14 years old;
  4. Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
  5. 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;
  6. Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Merge with tuberculosis patients;
  3. Combined with allergic asthma;
  4. Patients with nasal polyps or severe nasal septum deviation;
  5. Patients with serious systemic diseases or malignant tumors;
  6. Individuals with congenital genetic disorders or congenital immunodeficiency diseases;
  7. Regular use of probiotics or prebiotics within the first 6 months of the screening period;
  8. Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.);
  9. Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
  10. Patients with combined sinusitis, otitis media, or respiratory infections;
  11. Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data;
  12. Short term use of substances with similar functions to the test subject affects the judgment of the results;
  13. The subject is unable to participate in the trial due to personal reasons;
  14. Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Probiotic group

    Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure.

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo group

    No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotic

    The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)

  • Dietary supplementPlacebo

    The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 56 days

  2. 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

    Time frame: 56 days

  3. 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

    Time frame: 56 days

  4. 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.

    Time frame: 56 days

07

Study locations

1 site
  • Henan University of Science and Technology
    Luoyang, Henan 471000, China
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06676111
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Nov 6, 2024
Start date
Oct 10, 2024
Primary completion
Feb 10, 2025
Completion
Jul 31, 2025
Last update
Oct 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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