Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in the reflective total nasal symptom score (rTNSS)
研究概览
简要总结
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
详细描述
Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. The prevalence of AR has been reported from 5% to 50% worldwide which is dependent on the method of diagnosis and age of participants studied. AR is often co-morbid with asthma and/or conjunctivitis, which affects patients' daily life and carries a huge economic burden.
Increasing evidence showed that gut microbiota can influence the development of AR. Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut microbiota, refers to the transplantation of functional microbiota in the feces of healthy people into the intestines of patients. It can reconstruct the overall gut microbiota of patients, thus treating gastrointestinal disease and external gastrointestinal diseases of patients. Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. Compared with manual FMT, WMT can reduce the rate of adverseevents (such as fever, diarrhea, abdominal pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy.
In clinical practice, we found that WMT could significantly improve the nasal symptoms of AR. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old.
- •Meets the diagnostic criteria for allergic rhinitis.
- •rTNSS score greater than or equal to 6 points.
- •The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.
排除标准
- •Patients with acute nasosinusitis or upper respiratory tract infection.
- •Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
- •Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
- •Patients with poor lung function.
- •Patients with severe liver, kidney, and heart diseases
- •Patients with known psychiatric or neurological diseases.
- •Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks.
- •According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
研究组 & 干预措施
Washed microbiota transplantation
Patients take four capsules containing washed microbiota once a day for five consecutive days
干预措施: Washed Microbiota Transplantation (Drug)
Placebo
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the reflective total nasal symptom score (rTNSS)
时间窗: baseline, one weeks, four weeks, twelve weeks post WMT
TNSS is expressed as the sum of the scores for the four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).
次要结局
- Changes in the concentration of specific IgE(baseline, one day, four weeks, twelve weeks post WMT)
- Changes in the Modified Lund-Kennedy endoscopic score(baseline, four weeks, twelve weeks post WMT)
- Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score(baseline, one weeks, four weeks, twelve weeks post WMT)
- Changes in composition and metabolites of gut microbiota and nasal microbiota(baseline, one day, four weeks, twelve weeks post WMT)
- Changes in the concentration of inflammatory factors(baseline, one day, four weeks, twelve weeks post WMT)
- Changes in the single reflective nasal symptoms score(baseline, one weeks, four weeks, twelve weeks post WMT)
- The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0(One day, one week, four weeks, twelve weeks post WMT)
- Changes in the number of immune cell(baseline, one day, four weeks, twelve weeks post WMT)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University