Healthy Clinical Trial
— SASOfficial title:
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
Verified date | March 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 634 |
Est. completion date | February 5, 2018 |
Est. primary completion date | December 21, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Wakunaga Pharmaceutical Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score | Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo | Baseline (Week 0) to Final (Week 6) | |
Secondary | Change in diarrhea symptoms, measured by GSRS | Weekly GSRS diarrhea symptom scores in probiotic mixture vs. individual probiotic vs. placebo | Baseline (Week 0) to Final (Week 6) | |
Secondary | Change in abdominal pain symptoms, measured by GSRS | Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo | Baseline (Week 0) to Final (Week 6) | |
Secondary | Change in indigestion symptoms, measured by GSRS | Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo | Baseline (Week 0) to Final (Week 6) | |
Secondary | Change in reflux symptoms, measured by GSRS | Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo | Baseline (Week 0) to Final (Week 6) | |
Secondary | Weekly average of daily levels of stress | Daily stress (0 = no stress to 10 = severe or extreme stress) | Baseline (Week 0) to Final (Week 6) | |
Secondary | Microbiota studies, measured by 16S rRNA sequence analysis | Microbial diversity measured by 16S rRNA sequence analysis | Baseline (Week 0) and Week 5 | |
Secondary | Microbiota studies, qPCR | qPCR to quantify changes in bacteria of interest | Baseline (Week 0) and Week 5 | |
Secondary | 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) | Baseline (Week 0) to Final (Week 6) | |
Secondary | Immune function, measured by questionnaire data | Symptom intensity score (average sum of symptom intensities) | Baseline (Week 0) to Final (Week 6) |
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