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
1 other identifier
interventional
583
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Sep 2012
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 29, 2015
January 1, 2015
3 months
October 11, 2012
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
* Microbial diversity measured by DGGE profiling (detect large distortions) * qPCR to quantify treatment effects on specific bacteria
Change in microbiota from pre-baseline to on average week 4
Digestive Health
* 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)
Daily for 7 weeks
Secondary Outcomes (1)
Immune Health
Measured at pre-baseline and on average week 4
Study Arms (4)
Sugar Pill
PLACEBO COMPARATORSugar Pill will be taken as a capsule once daily for 6 weeks.
Probiotic- Bifidobacterium bifidum
EXPERIMENTALBifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.
Probiotic- Lactobacillus helveticus
EXPERIMENTALLactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.
Probiotic- Bifidobacterium longum ss. Infantis R0033
EXPERIMENTALBifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks.
Interventions
Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
Sugar Pill (Sucrose) 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.
Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Lallemand Human Nutritioncollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (2)
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.
PMID: 25604727RESULTCulpepper 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.
PMID: 26839075DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bobbi Langkamp-Henken, PhD, RD
University of Florida
- PRINCIPAL INVESTIGATOR
Wendy Dahl, PhD, RD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2012
First Posted
October 18, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
January 29, 2015
Record last verified: 2015-01