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临床试验/NCT01709825
NCT01709825已完成不适用

The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study

University of Florida1 个研究点 分布在 1 个国家目标入组 583 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
583
试验地点
1
主要终点
Proportion of days without cold/flu

研究概览

简要总结

The purpose of this study is to determine if daily consumption of a probiotic in the period before, during and after academic exams will help maintain digestive and immune health and quality of life of undergraduate students.

详细描述

A randomized, double-blinded, placebo-controlled trial will be used. Healthy full-time undergraduate students will be recruited from the University of Florida via flyers, emails, announcements, etc. Informed consent will be obtained and the inclusion/exclusion criteria will be reviewed to determine whether a participant qualifies for the study. All participants will be consented for the main six-week intervention and a subgroup (n=50/group) of these students will be consented to provide two stool samples.

Participants will provide saliva and stool samples (for the sub-group)during the pre-baseline week and during the week of final exams at approximately week 4. At the randomization visit, height, weight and age will be obtained. Participants will be stratified based on body mass index and randomized via sealed envelopes to one of four groups: Lactobacillus helveticus, Bifidobacterium longum ssp. Infantis, Bifidobacterium bifidum or the placebo (n=145/group). Participants will take the study provided capsule of probiotic or placebo daily for 6 weeks. Participants will receive daily questionnaires via email throughout the prebaseline week and the 6-week intervention. Daily questionnaires will ask about intake of the supplement, cold symptoms, and general health (i.e., new medications, doctor visits). Throughout the study, participants will also be asked to complete weekly questionnaires (inquiring about gastrointestinal symptoms and physical activity) and Quality of Life Questionnaires (administered during pre-baseline, final exam week and week 6 of the study).

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
Double (Participant, Investigator)

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

  • •To participate in the study you must:
  • •be 18 years of age or older.
  • •be a healthy full-time undergraduate at the University of Florida.
  • •be willing to complete daily questionnaires form via computer.
  • •be 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).
  • •be willing to take the probiotic capsule daily of 6 weeks.
  • •have had at least one cold in the last 12 months.
  • •have at least 1 final during the scheduled exam week.
  • •have daily access to the Internet.

排除标准

  • •To participate in the study you must NOT:
  • •be a current smoker.
  • •have chronic allergies involving the upper respiratory tract.
  • •have had immunosuppressive illness or treatment within the last year.
  • •have received antibiotic therapy in the past two months.

研究组 & 干预措施

Sugar Pill

Placebo Comparator

Sugar Pill will be taken as a capsule once daily for 6 weeks.

干预措施: Sugar Pill (Dietary Supplement)

Probiotic- Bifidobacterium bifidum

Experimental

Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.

干预措施: Probiotic- Bifidobacterium Bifidum (Dietary Supplement)

Probiotic- Lactobacillus helveticus

Experimental

Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.

干预措施: Probiotic- Lactobacillus helveticus (Dietary Supplement)

Probiotic- Bifidobacterium longum ss. Infantis R0033

Experimental

Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks.

干预措施: Probiotic- Bifidobacterium longum ss. Infantis R0033 (Dietary Supplement)

结局指标

主要结局

Proportion of days without cold/flu

时间窗: over 6 weeks

The intensity of cold/flu symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort)will be scored as 0 (not experiencing) to 3 (severe). The symptom intensity from the 9 cold/flu symptoms will be summed to obtain a symptom intensity score. A symptom intensity score of \>6 will be designated as a day of cold. The mean proportion of days without a cold/flu will be compared between each probiotic and the placebo.

Microbiota Study

时间窗: Change in microbiota from pre-baseline to on average week 4

* Microbial diversity measured by DGGE profiling (detect large distortions) * qPCR to quantify treatment effects on specific bacteria

Digestive Health

时间窗: Daily for 7 weeks

* Gastrointestinal symptoms (gas, bloating, diarrhea, etc.) * Bowel habits (bowel movement frequency and consistency) * Measures of quality of life (physical functioning, general health, bodily pain, vitality and social functioning)

次要结局

  • Immune Health(Measured at pre-baseline and on average week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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