Clinical trial NCT06885632: Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children
Official title: The Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Allergic Rhinitis
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Changes in the structure of fecal microbiota before and after the intervention.
timeFrame: Week 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The School of Food and Bioengineering, Henan University of Science and Technolog
state: He Nan
Study officials:
References: