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| Name | Class |
|---|---|
| Wakunaga Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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). |
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| Probiotic Combination | Experimental | A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Bifidobacterium bifidum | Experimental | A commercially available probiotic strain (Bifidobacterium bifidum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Bifidobacterium longum | Experimental | A commercially available probiotic strain (Bifidobacterium longum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in abdominal pain symptoms, measured by GSRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| Probiotic Combination | Dietary Supplement | 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). |
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| Bifidobacterium bifidum | Dietary Supplement | 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). |
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| Bifidobacterium longum | Dietary Supplement | 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. |
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Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo
| 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 | 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 | 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) | Baseline (Week 0) to Final (Week 6) |
| Microbiota studies, measured by 16S rRNA sequence analysis | Microbial diversity measured by 16S rRNA sequence analysis | Baseline (Week 0) and Week 5 |
| Microbiota studies, qPCR | qPCR to quantify changes in bacteria of interest | 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) | Baseline (Week 0) to Final (Week 6) |
| Immune function, measured by questionnaire data | Symptom intensity score (average sum of symptom intensities) | Baseline (Week 0) to Final (Week 6) |