Probiotics for treating allergic rhinitis in children
The Effectiveness of Probiotics 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 in children aged 4 to 14 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Luoyang, Henan) |
| Trial ID | NCT06676111 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of probiotic gummies in relieving symptoms of allergic rhinitis in children aged 4 to 14 years. Participants will receive either the probiotic treatment or a placebo, and the study will assess the clinical efficacy, changes in gut microbiota, serum metabolic profiles, and any adverse reactions. The goal is to determine if probiotics can provide a beneficial effect compared to standard treatment options.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-14 who meet the diagnostic criteria for allergic rhinitis and exhibit persistent symptoms.
Not a fit: Patients with severe systemic diseases, congenital immunodeficiency, or those who have recently used medications affecting intestinal flora may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, effective treatment option for children suffering from allergic rhinitis.
How similar studies have performed: Other studies have shown promising results with probiotics in managing allergic conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 4-14 years old; 2. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition); 3. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes; 4. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge; Exclusion Criteria: 1. Drugs that affect the intestinal flora 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. Subjects who are judged by other investigators to be insuitable to participate.
Where this trial is running
Luoyang, Henan
- Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.