Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lallemand Human Nutrition | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Sugar Pill will be taken as a capsule once daily for 6 weeks. |
|
| Probiotic- Bifidobacterium bifidum | Experimental | Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks. |
|
| Probiotic- Lactobacillus helveticus | Experimental | Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks. |
|
| Probiotic- Bifidobacterium longum ss. Infantis R0033 | Experimental | Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic- Bifidobacterium Bifidum | Dietary Supplement | Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over 6 weeks |
| Microbiota Study |
| Change in microbiota from pre-baseline to on average week 4 |
| Digestive Health |
| Daily for 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Health |
| Measured at pre-baseline and on average week 4 |
Not provided
Inclusion Criteria:
To participate in the study you must:
Exclusion Criteria:
To participate in the study you must NOT:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Wendy Dahl, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25604727 | Result | Langkamp-Henken B, Rowe CC, Ford AL, Christman MC, Nieves C Jr, Khouri L, Specht GJ, Girard SA, Spaiser SJ, Dahl WJ. Bifidobacterium bifidum R0071 results in a greater proportion of healthy days and a lower percentage of academically stressed students reporting a day of cold/flu: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2015 Feb 14;113(3):426-34. doi: 10.1017/S0007114514003997. Epub 2015 Jan 21. | |
| 26839075 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sugar Pill | Dietary Supplement | Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks. |
|
|
| Probiotic- Lactobacillus helveticus | Dietary Supplement | Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks. |
|
|
| Probiotic- Bifidobacterium longum ss. Infantis R0033 | Dietary Supplement | Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks. |
|
|
| Derived |
| Culpepper T, Christman MC, Nieves C Jr, Specht GJ, Rowe CC, Spaiser SJ, Ford AL, Dahl WJ, Girard SA, Langkamp-Henken B. Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. Benef Microbes. 2016 Jun;7(3):327-36. doi: 10.3920/BM2015.0156. Epub 2016 Feb 3. |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073893 | Sugars |
| D013395 | Sucrose |
| C091363 | ISL2 protein, Lactobacillus helveticus |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
Not provided
Not provided