Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

Not Applicable

Recruiting

• Conditions: Children With Allergic Rhinitis

• Registration Number: NCT06676111
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-10-10
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Primary Completion: 2024-12-10
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication scores	56 days	Scoring drugs include oral antihistamines (3 points/tablet, maximum 6 points), oral leukotriene receptor antagonists (2 points/dose), nasal glucocorticoids (1 point/spray, maximum 8 points), nasal spray or eye drops antihistamines (0.5 points/spray or drop, maximum 4 points), and the daily average score for the past 1 week was calculated.
Total Nasal Symptom Score (TNSS)	56 days	Score 0 - asymptomatic; Score 1 - mild symptoms, easily tolerated; Score 2 - moderate symptoms, annoying but tolerable; Score 3 - Severe symptoms, intolerable, affecting daily life and sleep. Add them together to get the total score
Visual Analogue Scale (VAS)	56 days	"0" means no such symptoms; "10" means that this symptom is the most severe. Add them together to get the total score
Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)	56 days	0 points: no trouble; 1 point: little to no distress; 2 points: occasional distress; Score 3: Moderate degree of distress; 4: Somewhat bothered, 5: Very bothered; Score 6: Extremely distressed

Trial Locations

Locations (1)

Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China