Status:
RECRUITING
Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Children With Allergic Rhinitis
Eligibility:
All Genders
4-14 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Voluntary, written, signed informed consent to participate in this study;
- be able to complete the study in accordance with the requirements of the test protocol;
- Age 4-14 years old;
- Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
- 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;
- Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;
Exclusion
- 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;
- Patients with pulmonary tuberculosis;
- Combined with allergic asthma;
- Those with nasal polyps or severe nasal septum deviation;
- Patients with severe systemic diseases or malignant tumors;
- Those with congenital genetic diseases and congenital immunodeficiency diseases;
- Those who regularly use probiotics or prebiotics within 6 months before the screening period;
- Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
- Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
- Patients with sinusitis, otitis media, or respiratory tract infection;
- Those who are allergic to the probiotic-related ingredients used in this trial;
- 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;
- Those who take items with similar functions to the test in a short period of time, which affects the judgment of the results;
- Subjects who are unable to participate in the test due to their own reasons;
- Subjects who are judged by other investigators to be insuitable to participate.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06885632
Start Date
March 10 2025
End Date
November 20 2025
Last Update
March 20 2025
Active Locations (1)
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1
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, China, 471000