NCT02349711已完成不适用
Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ
研究概览
简要总结
In this randomized, double-blind, placebo-controlled study, participants with seasonal allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse events, and compliance. In a subset of subjects, stool and blood samples will be collected at baseline and at week 6 of the intervention (estimated to be peak allergy season) to characterize microbial communities and immune function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- 是
入选标准
- •Subjects will be included if they:
- •are 18 to 60 years of age (inclusive).
- •receive a score of 2 or greater on the Mini Rhinoconjunctivitis Quality of Life Questionnaire.
- •are willing and able to complete the Informed Consent Form in English.
- •are available for 8 consecutive weeks to participate in this study.
- •be willing and able to complete online daily and weekly questionnaires regarding general wellness, bowel function, quality of life, gastrointestinal symptoms, and physical activity.
- •are willing and able to maintain their regular level of physical activity and diet for the 8-week study.
- •are able to take the study supplement without the aid of another person.
- •are willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements), or immune-enhancing supplements (e.g., Echinacea or fish oil).
- •are willing to provide 2 blood and 2 stool samples (subgroup only).
排除标准
- •Subjects will be excluded if they:
- •do not meet any of the above criteria.
- •use allergy medications, including nasal sprays, 5 or more days per week.
- •receive allergy shots.
- •are currently pregnant or attempting to get pregnant.
- •are currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
- •are currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer, etc.); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including GERD; or have a central venous catheter.
- •have received chemotherapy or other immune suppressing therapy within the last year.
结局指标
主要结局
Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ
时间窗: up to 8 weeks from date of randomization
MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)
次要结局
- Regulatory T Cells (Tregs)(baseline and week 6)
- Serum Total Immunoglobulin E (IgE)(baseline and week 6)
- Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire(weeks 0, 1, 2, 3, 4, 5, 6, 7)
研究者
研究点 (2)
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