Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

NCT ID: NCT06885632

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-11-20

Brief Summary

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.

Conditions

Children With Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Probiotic pectin gummies(500 million CFU)/2 pellets/day BC99

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Placebo group

No probiotic pectin gummies/2 pellets/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Interventions

Probiotic

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ying Wu, doctor

Role: primary

wuying2000@126.com

18639283502 ext. +86

Other Identifiers

WK20250314

Identifier Type: -

Identifier Source: org_study_id