A Randomized, Double-Blind, Placebo-Controlled Study on the Efficacy of Bifidobacterium Longum Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.
研究概览
简要总结
Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of gluten.
详细描述
This is a randomized, double-blind, placebo-controlled study. Sixty non-celiac gluten sensitive subjects will be randomized into one of two groups; Probiotic ES1 or placebo. For the duration of the study, subjects must adhere to a gluten-free diet, apart from a scheduled fixed gluten exposure of two slices of bread once daily. Subjects will be required to take 1 capsule before and after consuming the two slices of bread and score the severity of their symptoms in a diary provided for the duration of the study (7 days).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or non-pregnant, non-lactating females.
- •Documented or self-diagnosed gluten sensitivity that is well-controlled.
- •Negative celiac serology to eliminate Celiac Disease at screening.
- •Written informed consent prior to any screening procedure.
- •Ability and willingness to comply with study requirements.
- •Adherence to a gluten-free diet during period of the study and 1 week prior to the first dose.
- •BMI < 35 kg/m2.
排除标准
- •History of diagnosis of Celiac Disease.
- •Positive pregnancy test at screening.
- •Positive HIV, Hepatitis, or Tuberculosis infection.
- •History of substance abuse within last 5 years.
- •Alcohol consumption of > 2 standard drink equivalents per day.
- •Recent myocardial infarction within past 3 months, recent stroke within past 12 months, recent abdominal surgery within past 12 months, history of any malignancies and/or active treatment for a psychiatric disorder.
- •Use of systemic biologics within 6 months of the study.
- •Use of oral probiotics within 2 weeks of the study.
- •Use of NSAIDS or aspirin within 7 days of the study.
- •Use of immunosuppressants within 30 days of the study.
- •Family history (first degree relative) of Celiac Disease.
- •Received an investigational product within 1 month of study.
- •History of digestive enzyme deficiencies.
- •History of severe reactions to low doses of gluten/accidental exposure to gluten.
- •History of wheat allergy (positive reactions to the skin-prick test or the IgE blood test).
- •History of lactose, milk protein and/or FODMAP allergies.
- •Subjects who have an immune-compromised condition.
结局指标
主要结局
Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.
时间窗: Baseline to 7 days.
The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).
次要结局
- Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.(Baseline to 7 days.)
- Adverse event assessment(Baseline to 7 days.)