Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

Wecare Probiotics

Status: Completed

Conditions: Children With Allergic Rhinitis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06676111

WK2024009

Details and patient eligibility

About

To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.

Enrollment: 72 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary, written, and signed informed consent form, agreeing to participate in this study;
2. Capable of completing research according to the requirements of the experimental plan;
3. Age range: 4-14 years old;
4. Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
5. Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, tearing, and redness;
6. Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.

Exclusion criteria

1. Drugs that affect the intestinal flora (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening;
2. Merge with tuberculosis patients;
3. Combined with allergic asthma;
4. Patients with nasal polyps or severe nasal septum deviation;
5. Patients with serious systemic diseases or malignant tumors;
6. Individuals with congenital genetic disorders or congenital immunodeficiency diseases;
7. Regular use of probiotics or prebiotics within the first 6 months of the screening period;
8. Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
10. Patients with combined sinusitis, otitis media, or respiratory infections;
11. Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data;
12. Short term use of substances with similar functions to the test subject affects the judgment of the results;
13. The subject is unable to participate in the trial due to personal reasons;
14. Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure.

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure.

Treatment:

Dietary Supplement: Placebo