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

This study has been completed.
Sponsor:
Collaborator:
Lallemand Human Nutrition
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01709825
First received: October 11, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Probiotic- Bifidobacterium Bifidum
Dietary Supplement: Sugar Pill
Dietary Supplement: Probiotic- Lactobacillus helveticus
Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Proportion of days without cold/flu [ Time Frame: over 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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)


Secondary Outcome Measures:
  • Immune Health [ Time Frame: Measured at pre-baseline and on average week 4 ] [ Designated as safety issue: No ]
    • Salivary secretory immunoglobulin A (sIgA)
    • Fecal sIgA


Enrollment: 583
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Bifidobacterium bifidum
  • Supplement A
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.
Other Names:
  • Lactobacillus helveticus
  • Supplement B
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.
Other Names:
  • Bifidobacterium longum ss. Infantis R0033
  • Supplement C

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709825

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Human Nutrition
Investigators
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
Principal Investigator: Wendy Dahl, PhD, RD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01709825     History of Changes
Other Study ID Numbers: 403-2012
Study First Received: October 11, 2012
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
probiotics
cold
flu
immune function
microbiota

Additional relevant MeSH terms:
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014