- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709825
The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health
The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To participate in the study you must:
- be 18 years of age or older.
- be a healthy full-time undergraduate at the University of Florida.
- be willing to complete daily questionnaires form via computer.
- be 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).
- be willing to take the probiotic capsule daily of 6 weeks.
- have had at least one cold in the last 12 months.
- have at least 1 final during the scheduled exam week.
- have daily access to the Internet.
Exclusion Criteria:
To participate in the study you must NOT:
- be a current smoker.
- have chronic allergies involving the upper respiratory tract.
- have had immunosuppressive illness or treatment within the last year.
- have received antibiotic therapy in the past two months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar Pill
Sugar Pill will be taken as a capsule once daily for 6 weeks.
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Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
Other Names:
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Experimental: Probiotic- Bifidobacterium bifidum
Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.
|
Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
Other Names:
|
Experimental: Probiotic- Lactobacillus helveticus
Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.
|
Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
Other Names:
|
Experimental: Probiotic- Bifidobacterium longum ss. Infantis R0033
Bifidobacterium longum ss.
Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks.
|
Bifidobacterium longum ss.
Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of days without cold/flu
Time Frame: over 6 weeks
|
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.
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over 6 weeks
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Microbiota Study
Time Frame: Change in microbiota from pre-baseline to on average week 4
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Change in microbiota from pre-baseline to on average week 4
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Digestive Health
Time Frame: Daily for 7 weeks
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Daily for 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Health
Time Frame: Measured at pre-baseline and on average week 4
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Measured at pre-baseline and on average week 4
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy Dahl, PhD, RD, University of Florida
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 403-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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