The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01709825|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : January 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Probiotic- Bifidobacterium Bifidum Dietary Supplement: Sugar Pill Dietary Supplement: Probiotic- Lactobacillus helveticus Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||583 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Placebo Comparator: Sugar Pill
Sugar Pill will be taken as a capsule once daily for 6 weeks.
Dietary Supplement: Sugar Pill
Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
Other Name: Sucrose
Experimental: Probiotic- Bifidobacterium bifidum
Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.
Dietary Supplement: Probiotic- Bifidobacterium Bifidum
Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
Experimental: Probiotic- Lactobacillus helveticus
Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.
Dietary Supplement: Probiotic- Lactobacillus helveticus
Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
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.
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.
- 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)
- Immune Health [ Time Frame: Measured at pre-baseline and on average week 4 ]
- Salivary secretory immunoglobulin A (sIgA)
- Fecal sIgA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709825
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Bobbi Langkamp-Henken, PhD, RD||University of Florida|
|Principal Investigator:||Wendy Dahl, PhD, RD||University of Florida|