The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health

Tracking Information
First Submitted Date ICMJE	October 11, 2012
First Posted Date ICMJE	October 18, 2012
Last Update Posted Date	January 29, 2015
Study Start Date ICMJE	September 2012
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 16, 2012)	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.; Microbiota Study [ Time Frame: Change in microbiota from pre-baseline to on average week 4 ] Microbial diversity measured by DGGE profiling (detect large distortions) qPCR to quantify treatment effects on specific bacteria; Digestive Health [ Time Frame: Daily for 7 weeks ] Gastrointestinal symptoms (gas, bloating, diarrhea, etc.) Bowel habits (bowel movement frequency and consistency) Measures of quality of life (physical functioning, general health, bodily pain, vitality and social functioning)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01709825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 16, 2012)	Immune Health [ Time Frame: Measured at pre-baseline and on average week 4 ]; Salivary secretory immunoglobulin A (sIgA); Fecal sIgA
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health
Official Title ICMJE	The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study
Brief Summary	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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
Condition ICMJE	Healthy
Intervention ICMJE	Dietary Supplement: Probiotic- Bifidobacterium Bifidum Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks. Other Names: Bifidobacterium bifidum Supplement A; Dietary Supplement: Sugar Pill Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks. Other Name: Sucrose; Dietary Supplement: Probiotic- Lactobacillus helveticus Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks. Other Names: Lactobacillus helveticus Supplement B; Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033 Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks. Other Names: Bifidobacterium longum ss. Infantis R0033 Supplement C
Study Arms	Placebo Comparator: Sugar Pill Sugar Pill will be taken as a capsule once daily for 6 weeks. Intervention: Dietary Supplement: Sugar Pill; Experimental: Probiotic- Bifidobacterium bifidum Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks. Intervention: Dietary Supplement: Probiotic- Bifidobacterium Bifidum; Experimental: Probiotic- Lactobacillus helveticus Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks. Intervention: Dietary Supplement: Probiotic- Lactobacillus helveticus; 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. Intervention: Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 11, 2013)	583
Original Estimated Enrollment ICMJE; (submitted: October 16, 2012)	580
Actual Study Completion Date	January 2013
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01709825
Other Study ID Numbers ICMJE	403-2012
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Florida
Study Sponsor ICMJE	University of Florida
Collaborators ICMJE	Lallemand Human Nutrition
Investigators ICMJE	Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida Principal Investigator: Wendy Dahl, PhD, RD University of Florida
PRS Account	University of Florida
Verification Date	January 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP