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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
583
Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
University of Florida
Gainesville, Florida, United States
Proportion of days without cold/flu
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.
Time frame: over 6 weeks
Microbiota Study
* Microbial diversity measured by DGGE profiling (detect large distortions) * qPCR to quantify treatment effects on specific bacteria
Time frame: Change in microbiota from pre-baseline to on average week 4
Digestive Health
* 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)
Time frame: Daily for 7 weeks
Immune Health
* Salivary secretory immunoglobulin A (sIgA) * Fecal sIgA
Time frame: Measured at pre-baseline and on average week 4
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Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.