The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Medication scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary, written, and signed informed consent form, agreeing to participate in this study;
- •Capable of completing research according to the requirements of the experimental plan;
- •Age range: 4-14 years old;
- •Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
- •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;
- •Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.
排除标准
- •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;
- •Merge with tuberculosis patients;
- •Combined with allergic asthma;
- •Patients with nasal polyps or severe nasal septum deviation;
- •Patients with serious systemic diseases or malignant tumors;
- •Individuals with congenital genetic disorders or congenital immunodeficiency diseases;
- •Regular use of probiotics or prebiotics within the first 6 months of the screening period;
- •Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.);
- •Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
- •Patients with combined sinusitis, otitis media, or respiratory infections;
- •Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data;
- •Short term use of substances with similar functions to the test subject affects the judgment of the results;
- •The subject is unable to participate in the trial due to personal reasons;
- •Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.
研究组 & 干预措施
Placebo group
No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure.
干预措施: Placebo (Dietary Supplement)
Probiotic group
Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Medication scores
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点