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

January 27, 2015 updated by: University of Florida

The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

583

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Dietary supplement: Sugar Pill
Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
Other Names:
  • 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

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.
over 6 weeks
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
Change in microbiota from pre-baseline to on average week 4
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)
Daily for 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Health
Time Frame: Measured at pre-baseline and on average week 4
  • Salivary secretory immunoglobulin A (sIgA)
  • Fecal sIgA
Measured at pre-baseline and on average week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Lallemand Human Nutrition

Investigators

  • Principal Investigator: Wendy Dahl, PhD, RD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

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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