Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

The Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile

To evaluate the effect of probiotic gummies on serum metabolite levels, clinical efficacy, and regulation of gut microbiota in children with allergic rhinitis compared with placebo.

Study Overview

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

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

Contacts and Locations

Study Locations

• China
  • He Nan
    • Luoyang, He Nan, China, 471000
      • Recruiting
      • The School of Food and Bioengineering, Henan University of Science and Technolog
      • Contact: Ying Wu, doctor; Phone Number: +86 18639283502; Email: wuying2000@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Voluntary, written, signed informed consent to participate in this study;
2. be able to complete the study in accordance with the requirements of the test protocol;
3. Age 4-14 years old;
4. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
5. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;
6. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;

Exclusion Criteria:

1. Drugs that affect the intestinal flora (including antimicrobial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening;
2. Patients with pulmonary tuberculosis;
3. Combined with allergic asthma;
4. Those with nasal polyps or severe nasal septum deviation;
5. Patients with severe systemic diseases or malignant tumors;
6. Those with congenital genetic diseases and congenital immunodeficiency diseases;
7. Those who regularly use probiotics or prebiotics within 6 months before the screening period;
8. Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
10. Patients with sinusitis, otitis media, or respiratory tract infection;
11. Those who are allergic to the probiotic-related ingredients used in this trial;
12. Those who stop taking the test sample or add other drugs in the middle of the test, and the efficacy cannot be judged or the data is incomplete;
13. Those who take items with similar functions to the test in a short period of time, which affects the judgment of the results;
14. Subjects who are unable to participate in the test due to their own reasons;
15. Subjects who are judged by other investigators to be insuitable to participate.

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
Experimental: Probiotic group; Probiotic pectin gummies(500 million CFU)/2 pellets/day BC99	Dietary supplement: Probiotic; The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).
Placebo Comparator: Placebo group; No probiotic pectin gummies/2 pellets/day	Dietary supplement: Placebo; The experimental phase of this study lasts 56 days 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 in the structure of fecal microbiota before and after the intervention.	Analyzed by 16S rRNA sequencing.	Week 0 and Week 8

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): August 10, 2025
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 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
• 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