Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) on Stress-associated Gastrointestinal Function in University Students: a Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
研究概览
简要总结
The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.
详细描述
In this randomized, double-blind, placebo-controlled study, undergraduate students planning to take a fall final exam will receive a daily probiotic combination, individual probiotic, or placebo for 6 weeks. Questionnaires will assess gastrointestinal symptoms, immune health, stress and stress management, quality of life, diet, adverse events, and compliance. In a subset of subjects, stool samples will be collected at baseline and at week 5 of the intervention (the week before final exams) to characterize microbial communities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Healthy full-time undergraduate student at the University of Florida
- •Willing and able to consume a daily supplement (probiotic or placebo) for the duration of the 6-week study
- •Willing and able to complete daily questionnaires online regarding general health and well-being, including stress levels and gastrointestinal symptoms (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided)
- •Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E [>400% of the RDA or >60 mg/day])
- •Had a cold/flu within the past year
排除标准
- •Currently smoke
- •Women who are lactating, know that they are pregnant, or are attempting to get pregnant
- •Currently taking any systemic corticosteroids
- •Currently being treated for any physician-diagnosed diseases
- •Have received chemotherapy or other immune suppressing therapy within the last year
研究组 & 干预措施
Placebo
Placebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
干预措施: Placebo (Dietary Supplement)
Probiotic Combination
A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
干预措施: Probiotic Combination (Dietary Supplement)
Bifidobacterium longum
A commercially available probiotic strain (Bifidobacterium longum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
干预措施: Bifidobacterium longum (Dietary Supplement)
Bifidobacterium bifidum
A commercially available probiotic strain (Bifidobacterium bifidum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
干预措施: Bifidobacterium bifidum (Dietary Supplement)
结局指标
主要结局
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
时间窗: Baseline (Week 0) to Final (Week 6)
Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo
次要结局
- Change in reflux symptoms, measured by GSRS(Baseline (Week 0) to Final (Week 6))
- Change in diarrhea symptoms, measured by GSRS(Baseline (Week 0) to Final (Week 6))
- Change in abdominal pain symptoms, measured by GSRS(Baseline (Week 0) to Final (Week 6))
- Change in indigestion symptoms, measured by GSRS(Baseline (Week 0) to Final (Week 6))
- Weekly average of daily levels of stress(Baseline (Week 0) to Final (Week 6))
- Microbiota studies, measured by 16S rRNA sequence analysis(Baseline (Week 0) and Week 5)
- Immune health, measured by questionnaire data(Baseline (Week 0) to Final (Week 6))
- Microbiota studies, qPCR(Baseline (Week 0) and Week 5)
- Immune function, measured by questionnaire data(Baseline (Week 0) to Final (Week 6))