<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709825</url>
  </required_header>
  <id_info>
    <org_study_id>403-2012</org_study_id>
    <nct_id>NCT01709825</nct_id>
  </id_info>
  <brief_title>The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health</brief_title>
  <official_title>The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lallemand Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if daily consumption of a probiotic in the period&#xD;
      before, during and after academic exams will help maintain digestive and immune health and&#xD;
      quality of life of undergraduate students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blinded, placebo-controlled trial will be used. Healthy full-time&#xD;
      undergraduate students will be recruited from the University of Florida via flyers, emails,&#xD;
      announcements, etc. Informed consent will be obtained and the inclusion/exclusion criteria&#xD;
      will be reviewed to determine whether a participant qualifies for the study. All participants&#xD;
      will be consented for the main six-week intervention and a subgroup (n=50/group) of these&#xD;
      students will be consented to provide two stool samples.&#xD;
&#xD;
      Participants will provide saliva and stool samples (for the sub-group)during the pre-baseline&#xD;
      week and during the week of final exams at approximately week 4. At the randomization visit,&#xD;
      height, weight and age will be obtained. Participants will be stratified based on body mass&#xD;
      index and randomized via sealed envelopes to one of four groups: Lactobacillus helveticus,&#xD;
      Bifidobacterium longum ssp. Infantis, Bifidobacterium bifidum or the placebo (n=145/group).&#xD;
      Participants will take the study provided capsule of probiotic or placebo daily for 6 weeks.&#xD;
      Participants will receive daily questionnaires via email throughout the prebaseline week and&#xD;
      the 6-week intervention. Daily questionnaires will ask about intake of the supplement, cold&#xD;
      symptoms, and general health (i.e., new medications, doctor visits). Throughout the study,&#xD;
      participants will also be asked to complete weekly questionnaires (inquiring about&#xD;
      gastrointestinal symptoms and physical activity) and Quality of Life Questionnaires&#xD;
      (administered during pre-baseline, final exam week and week 6 of the study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of days without cold/flu</measure>
    <time_frame>over 6 weeks</time_frame>
    <description>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 &gt;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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiota Study</measure>
    <time_frame>Change in microbiota from pre-baseline to on average week 4</time_frame>
    <description>Microbial diversity measured by DGGE profiling (detect large distortions)&#xD;
qPCR to quantify treatment effects on specific bacteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Digestive Health</measure>
    <time_frame>Daily for 7 weeks</time_frame>
    <description>Gastrointestinal symptoms (gas, bloating, diarrhea, etc.)&#xD;
Bowel habits (bowel movement frequency and consistency)&#xD;
Measures of quality of life (physical functioning, general health, bodily pain, vitality and social functioning)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune Health</measure>
    <time_frame>Measured at pre-baseline and on average week 4</time_frame>
    <description>Salivary secretory immunoglobulin A (sIgA)&#xD;
Fecal sIgA</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">583</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugar Pill will be taken as a capsule once daily for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic- Bifidobacterium bifidum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic- Lactobacillus helveticus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic- Bifidobacterium longum ss. Infantis R0033</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic- Bifidobacterium Bifidum</intervention_name>
    <description>Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.</description>
    <arm_group_label>Probiotic- Bifidobacterium bifidum</arm_group_label>
    <other_name>Bifidobacterium bifidum</other_name>
    <other_name>Supplement A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sugar Pill</intervention_name>
    <description>Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.</description>
    <arm_group_label>Sugar Pill</arm_group_label>
    <other_name>Sucrose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic- Lactobacillus helveticus</intervention_name>
    <description>Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.</description>
    <arm_group_label>Probiotic- Lactobacillus helveticus</arm_group_label>
    <other_name>Lactobacillus helveticus</other_name>
    <other_name>Supplement B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic- Bifidobacterium longum ss. Infantis R0033</intervention_name>
    <description>Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.</description>
    <arm_group_label>Probiotic- Bifidobacterium longum ss. Infantis R0033</arm_group_label>
    <other_name>Bifidobacterium longum ss. Infantis R0033</other_name>
    <other_name>Supplement C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To participate in the study you must:&#xD;
&#xD;
          -  be 18 years of age or older.&#xD;
&#xD;
          -  be a healthy full-time undergraduate at the University of Florida.&#xD;
&#xD;
          -  be willing to complete daily questionnaires form via computer.&#xD;
&#xD;
          -  be willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics&#xD;
             and fiber supplements, probiotics, echinacea, fish oil, vitamin E &gt;400% of the RDA or&#xD;
             &gt;60 mg/day).&#xD;
&#xD;
          -  be willing to take the probiotic capsule daily of 6 weeks.&#xD;
&#xD;
          -  have had at least one cold in the last 12 months.&#xD;
&#xD;
          -  have at least 1 final during the scheduled exam week.&#xD;
&#xD;
          -  have daily access to the Internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        To participate in the study you must NOT:&#xD;
&#xD;
          -  be a current smoker.&#xD;
&#xD;
          -  have chronic allergies involving the upper respiratory tract.&#xD;
&#xD;
          -  have had immunosuppressive illness or treatment within the last year.&#xD;
&#xD;
          -  have received antibiotic therapy in the past two months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bobbi Langkamp-Henken, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wendy Dahl, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>25604727</PMID>
  </results_reference>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>probiotics</keyword>
  <keyword>cold</keyword>
  <keyword>flu</keyword>
  <keyword>immune function</keyword>
  <keyword>microbiota</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulfalene</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709825
org study id: 403-2012
nct id: NCT01709825
lead sponsor: 
collaborator: 
has dmc: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Proportion of days without cold/flu
time frame: over 6 weeks
description: 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.
measure: Microbiota Study
time frame: Change in microbiota from pre-baseline to on average week 4
description: Microbial diversity measured by DGGE profiling (detect large distortions)
qPCR to quantify treatment effects on specific bacteria
measure: Digestive Health
time frame: Daily for 7 weeks
description: 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)
measure: Immune Health
time frame: Measured at pre-baseline and on average week 4
description: Salivary secretory immunoglobulin A (sIgA)
Fecal sIgA
arm group label: Sugar Pill
arm group type: Placebo Comparator
description: Sugar Pill will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Bifidobacterium bifidum
arm group type: Experimental
description: Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Lactobacillus helveticus
arm group type: Experimental
description: Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Bifidobacterium longum ss. Infantis R0033
arm group type: Experimental
description: Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks.
intervention type: Dietary Supplement
intervention name: Probiotic- Bifidobacterium Bifidum
description: Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Bifidobacterium bifidum
other name: Bifidobacterium bifidum
other name: Supplement A
intervention type: Dietary Supplement
intervention name: Sugar Pill
description: Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
arm group label: Sugar Pill
other name: Sucrose
intervention type: Dietary Supplement
intervention name: Probiotic- Lactobacillus helveticus
description: Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Lactobacillus helveticus
other name: Lactobacillus helveticus
other name: Supplement B
intervention type: Dietary Supplement
intervention name: Probiotic- Bifidobacterium longum ss. Infantis R0033
description: Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.
arm group label: Probiotic- Bifidobacterium longum ss. Infantis R0033
other name: Bifidobacterium longum ss. Infantis R0033
other name: Supplement C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bobbi Langkamp-Henken, PhD, RD
role: Principal Investigator
affiliation: University of Florida
last name: Wendy Dahl, PhD, RD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: 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: 25604727
responsible party type: Sponsor
mesh term: Sulfalene