Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Sintomi Della Rinite Allergica Perenne E Stagionale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total nasal symptom score (TNSS)
研究概览
简要总结
The purpose of the current study is to evaluate the efficacy of administering a multistrain probiotic in adult human subjects suffering from allergic rhinitis and evaluate both symptomatology through validated questionnaires and gut microbiota modification during and after treatment.
详细描述
Adult subjects (18-60) with documented allergic rhinitis will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks. Total nasal symptom score (TNSS), Rhinitis Control Assessment Test (RCAT), Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) will be compared over 12 weeks between the two treatment groups. In addition, serological markers (Eosinophil count, Total IgE and Eosinophilic cationic protein) and gut microbiota features will be evaluated over a 12 week period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years of age
- •Established allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)
- •Positive Skin Prick Test and/or Specific IgE to at least one aeroallergen.
- •Have signed the consent form
- •Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period
排除标准
- •Subjects currently under treatment with antibiotics
- •Subjects undergoing allergen immunotherapy
- •Pregnancy
- •Vasomotor rhinitis
- •Nasal cavity disorders
- •Ear infections
- •Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
- •Subjects diagnosed with non-controlled asthma
- •Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
- •Subjects on chronic use of systemic corticosteroids
- •Proton pump inhibitors 2-weeks prior to randomization
- •Antibiotics 2-weeks prior to randomization
结局指标
主要结局
Total nasal symptom score (TNSS)
时间窗: over 8 weeks + 4 week after the end of trial (follow-up)
Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups + after 4 weeks from the end of trial.
次要结局
- Gut Microbiota changes on fecal samples(over 8 weeks + 4 week after the end of trial (follow-up))
- Rhinitis Control Assessment Test (RCAT)(over 8 weeks + 4 week after the end of trial (follow-up))
- Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)(over 8 weeks + 4 week after the end of trial (follow-up))
- Serological markers(over 8 weeks + 4 week after the end of trial (follow-up))
研究者
Giacomo Caio
Professor, MD, PhD
Università degli Studi di Ferrara