Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • The School of Food and Bioengineering, Henan University of Science and Technolog

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

1. 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;
2. patients with pulmonary tuberculosis;
3. patients with allergic asthma;
4. patients with nasal polyps or severe nasal septum deviation;
5. patients with severe systemic diseases or malignant tumors;
6. patients with congenital genetic diseases or congenital immune deficiency diseases;
7. patients who have regularly used probiotics or prebiotics within 6 months prior to screening;
8. patients with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. patients with metabolic syndrome symptoms (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
10. patients with sinusitis, otitis media, or respiratory tract infections;
11. patients who are allergic to the components of the probiotics used in this trial;
12. patients who have stopped taking the test sample or have taken other drugs midway, making it impossible to determine efficacy or having incomplete data;
13. patients whose recent use of substances with functions similar to the test sample could interfere with the accurate judgment of the trial results;
14. subjects who are unable to participate in the trial due to their own reasons; (15) other subjects deemed ineligible for participation by the researchers.

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	Dietary supplement: Placebo; The experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8).
Experimental: Probiotic group; Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99	Dietary supplement: Probiotic; The experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 0 and Week 8

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

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: WK20250314

Drug and device information, study documents

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