Healthy
Conditions
Keywords
probiotic, gastrointestinal, stress, student
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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).
DIETARY_SUPPLEMENTProbiotic Combination
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).
DIETARY_SUPPLEMENTBifidobacterium bifidum
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).
DIETARY_SUPPLEMENTBifidobacterium longum
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.
Sponsors
Wakunaga Pharmaceutical Co., Ltd.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score | Baseline (Week 0) to Final (Week 6) | Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal pain symptoms, measured by GSRS | Baseline (Week 0) to Final (Week 6) | Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo |
| Change in indigestion symptoms, measured by GSRS | Baseline (Week 0) to Final (Week 6) | Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo |
| Change in reflux symptoms, measured by GSRS | Baseline (Week 0) to Final (Week 6) | Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo |
| Weekly average of daily levels of stress | Baseline (Week 0) to Final (Week 6) | Daily stress (0 = no stress to 10 = severe or extreme stress) |
| Change in diarrhea symptoms, measured by GSRS | Baseline (Week 0) to Final (Week 6) | Weekly GSRS diarrhea symptom scores in probiotic mixture vs. individual probiotic vs. placebo |
| Microbiota studies, qPCR | Baseline (Week 0) and Week 5 | qPCR to quantify changes in bacteria of interest |
| Immune health, measured by questionnaire data | Baseline (Week 0) to Final (Week 6) | 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) |
| Immune function, measured by questionnaire data | Baseline (Week 0) to Final (Week 6) | Symptom intensity score (average sum of symptom intensities) |
| Microbiota studies, measured by 16S rRNA sequence analysis | Baseline (Week 0) and Week 5 | Microbial diversity measured by 16S rRNA sequence analysis |
Countries
United States
Outcome results
None listed