Probiotic gummies for 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

This study is testing if probiotic gummies can help relieve allergy symptoms like sneezing and stuffy noses in children aged 4 to 14.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 4 Years to 14 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (industry)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT06885632 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of probiotic gummies in improving symptoms of allergic rhinitis in children aged 4 to 14 years. Participants will be given either the probiotic gummies or a placebo to compare their effects on serum metabolite levels, clinical efficacy, and gut microbiota regulation. The study aims to determine if the probiotics can alleviate symptoms such as sneezing, nasal congestion, and watery eyes associated with allergic rhinitis. The research will follow strict eligibility criteria to ensure appropriate participant selection.

Who should consider this trial

Good fit: Ideal candidates are children aged 4-14 years who have been diagnosed with allergic rhinitis and exhibit multiple symptoms.

Not a fit: Patients who have recently used medications affecting intestinal flora or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel, non-pharmaceutical option for managing allergic rhinitis in children.

How similar studies have performed: While there is ongoing interest in the use of probiotics for various conditions, this specific approach in treating allergic rhinitis in children is relatively novel and has not been extensively tested.

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.

Where this trial is running

Luoyang, Henan

• The School of Food and Bioengineering, Henan University of Science and Technolog — Luoyang, Henan, China (RECRUITING)

Conditions: Children With Allergic Rhinitis