Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children

Inclusion Criteria:

1. Voluntarily, in writing, sign the informed consent form, agreeing to participate inthis study;

2. Capable of completing the study according to the test protocol requirements;

3. Age between 4 to 12 years old;

4. Meet the diagnostic criteria for allergic rhinitis established in the "ChineseGuidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)";

5. Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea,nasal itching, and nasal congestion, with symptoms lasting or accumulating for morethan one hour per day, possibly accompanied by eye itching, tearing, and redness,and other ocular symptoms;

6. Signs: Nasal mucosa is pale and edematous, possibly with watery secretions;

7. Laboratory tests: At least one allergen detected by skin prick test and/or specificIgE positivity in serum;

8. No use of antihistamines, corticosteroids, or immunosuppressants in the month beforescreening;

9. No history of heart, liver, kidney, nervous system, mental disorders, or metabolicabnormalities.

Exclusion Criteria:

1. Use of medications affecting the gut microbiota (including antimicrobial drugs,probiotics, intestinal mucosal protective agents, traditional Chinese patentmedicines, etc.) for more than 1 week within 1 month prior to screening;

2. Patients with coexisting pulmonary tuberculosis;

3. Those with coexisting allergic asthma;

4. Individuals with nasal polyps or severe nasal septal deviation;

5. Patients with severe systemic diseases or malignant tumors;

6. Those with congenital genetic diseases or congenital immunodeficiency diseases;

7. Regular use of probiotics or prebiotics within 6 months prior to the screeningperiod;

8. Individuals with severe gastrointestinal diseases (including severe diarrhea,inflammatory bowel diseases, etc.);

9. Those with metabolic syndrome (including obesity, dyslipidemia, hypertension,diabetes, etc.);

10. Individuals with sinusitis, otitis media, or respiratory tract infections;

11. Those allergic to any components of the probiotics used in this trial;

12. Women who are pregnant or breastfeeding, or those planning to conceive in the nearfuture;

13. Subjects who discontinue the test sample or add other medications midway, making itimpossible to determine efficacy or with incomplete information;

14. Those who have recently consumed items similar to the test product, affecting thejudgment of the results;

15. Subjects who, due to their own reasons, cannot participate in the trial;

16. Any other subjects deemed unsuitable to participate by the investigators.