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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
634
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).
A capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
University of Florida
Gainesville, Florida, United States
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo
Time frame: Baseline (Week 0) to Final (Week 6)
Change in diarrhea symptoms, measured by GSRS
Weekly GSRS diarrhea symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Time frame: Baseline (Week 0) to Final (Week 6)
Change in abdominal pain symptoms, measured by GSRS
Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Time frame: Baseline (Week 0) to Final (Week 6)
Change in indigestion symptoms, measured by GSRS
Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Time frame: Baseline (Week 0) to Final (Week 6)
Change in reflux symptoms, measured by GSRS
Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Time frame: Baseline (Week 0) to Final (Week 6)
Weekly average of daily levels of stress
Daily stress (0 = no stress to 10 = severe or extreme stress)
Time frame: Baseline (Week 0) to Final (Week 6)
Microbiota studies, measured by 16S rRNA sequence analysis
Microbial diversity measured by 16S rRNA sequence analysis
Time frame: Baseline (Week 0) and Week 5
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A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
Microbiota studies, qPCR
qPCR to quantify changes in bacteria of interest
Time frame: Baseline (Week 0) and Week 5
Immune health, measured by questionnaire data
Proportion of healthy days (i.e., days without cold symptoms with an intensity \>6). Daily health questionnaires ask students about non-allergy-related cold symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort) and symptom intensity (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Baseline (Week 0) to Final (Week 6)
Immune function, measured by questionnaire data
Symptom intensity score (average sum of symptom intensities)
Time frame: Baseline (Week 0) to Final (Week 6)