Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

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.

Study Overview

• Status: Completed
• Conditions: Children With Allergic Rhinitis
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • Henan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure.	Dietary supplement: Placebo; The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)
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; The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	56 days

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: WK2024009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No