<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/NCT01662206</url>
  </required_header>
  <id_info>
    <org_study_id>236-2012</org_study_id>
    <secondary_id>236-2012</secondary_id>
    <nct_id>NCT01662206</nct_id>
  </id_info>
  <brief_title>Probiotics (L. Gasseri, B. Bifidum, B. Longum) on Immune and Intestinal Health in Healthy Older Adults</brief_title>
  <official_title>Probiotics (Lactobacillus Gasseri, Bifidobacterium Bifidum, Bifidobacterium Longum) on Immune and Intestinal Health in Healthy Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 whether healthy older adults, aged 65 to 80 years,&#xD;
      consuming a probiotic each day for three weeks will have improved immune strength and&#xD;
      digestive health. It is hypothesized that older adults consuming the probiotics will see a&#xD;
      shift in their microbiota towards the &quot;healthy&quot; bacteria resulting in a greater proportion of&#xD;
      immune cells, decreased inflammation, and better digestive health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo controlled crossover design with two 3-week&#xD;
      interventions and a 5-week washout period in between. Thirty-six participants will be&#xD;
      enrolled. With informed consent, the daily questionnaire will be administered and a baseline&#xD;
      stool sample will be obtained during the week before the start of each intervention period.&#xD;
      Blood and saliva will be collected on the first and last day of each intervention period to&#xD;
      assess immune function. A final stool sample will be obtained in the last week of the&#xD;
      intervention period. Nutritional status, which can impact immune function, will be assessed&#xD;
      using the Mini-Nutritional Assessment, Block Fiber Screen, and the Block 2005 Food Frequency&#xD;
      Questionnaire. Daily questionnaires will record intake of the probiotic or placebo, level of&#xD;
      stress, hours of sleep, visits to the physician, new medications, number of stools, etc. The&#xD;
      Gastrointestinal Symptom Response Scale, which records gastrointestinal symptoms, such as&#xD;
      bloating, gas, diarrhea, and constipation, over the past week will be completed at baseline&#xD;
      and weekly during the interventions and the week following the interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cytokine production</measure>
    <time_frame>Measured at baseline and after 3 weeks of supplementation for each arm</time_frame>
    <description>Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in bacterial species measured in fecal samples</measure>
    <time_frame>Measured at baseline and after 3 weeks of supplementation for each arm</time_frame>
    <description>Microbial diversity measured by 454 16S rRNA sequence analysis&#xD;
qPCR to quantify changes in bacteria of interest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in digestive symptoms on the Gastrointestinal Symptom Response Scale</measure>
    <time_frame>Measured at baseline, weeks 1, 2, 3 and 4 of each arm</time_frame>
    <description>Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mucosal immune function</measure>
    <time_frame>Measured at baseline and after 3 weeks of supplementation for each arm</time_frame>
    <description>sIgA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules containing placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 capsules daily containing 348.25 mg of potato starch</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 to 80 years of age.&#xD;
&#xD;
          -  willing and able to complete the Informed Consent Form in English&#xD;
&#xD;
          -  willing to provide demographic information (age, race)&#xD;
&#xD;
          -  willing and able to complete daily and weekly questionnaires regarding general&#xD;
             wellness, bowel function and gastrointestinal symptoms.&#xD;
&#xD;
          -  willing to provide 4 blood, 4 stool, and 4 saliva samples&#xD;
&#xD;
          -  willing to discontinue any immune-enhancing dietary supplements ( e.g., prebiotics&#xD;
             supplements, Echinacea, fish oil, vitamin E &gt;200% of the RDA).&#xD;
&#xD;
          -  able to take the study probiotic without the aid of another person.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not meet the above criteria.&#xD;
&#xD;
          -  taking any medication for constipation or diarrhea.&#xD;
&#xD;
          -  currently taking any anti-inflammatory drugs on a regular basis.&#xD;
&#xD;
          -  current smoker.&#xD;
&#xD;
          -  typically consume fermented foods or probiotics (e.g., yogurts with live, active&#xD;
             cultures or supplements).&#xD;
&#xD;
          -  currently being treated for or have any of the following physician- diagnosed diseases&#xD;
             or conditions: HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer,&#xD;
             etc.), kidney disease, diabetes or gastrointestinal disease or conditions (such as&#xD;
             ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease,&#xD;
             Celiac disease, short bowel disease, ileostomy, colostomy) other than GERD or&#xD;
             diverticular disease or have a central venous catheter.&#xD;
&#xD;
          -  received chemotherapy or other immune suppressing therapy within the last year.&#xD;
&#xD;
          -  received antibiotic therapy in the past two months.&#xD;
&#xD;
          -  cannot schedule planned immunizations to at least 4 weeks before the start of the&#xD;
             study, in the week following the second blood draw, or after the 4th blood draw.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</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>
  <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>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>April 15, 2013</last_update_submitted>
  <last_update_submitted_qc>April 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adults</keyword>
  <keyword>probiotics</keyword>
  <keyword>immune function</keyword>
  <keyword>microbiota</keyword>
  <keyword>digestive health</keyword>
  <!-- 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/NCT01662206
org study id: 236-2012
secondary id: 236-2012
nct id: NCT01662206
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years,
      consuming a probiotic each day for three weeks will have improved immune strength and
      digestive health. It is hypothesized that older adults consuming the probiotics will see a
      shift in their microbiota towards the "healthy" bacteria resulting in a greater proportion of
      immune cells, decreased inflammation, and better digestive health.
This is a randomized, double-blind, placebo controlled crossover design with two 3-week
      interventions and a 5-week washout period in between. Thirty-six participants will be
      enrolled. With informed consent, the daily questionnaire will be administered and a baseline
      stool sample will be obtained during the week before the start of each intervention period.
      Blood and saliva will be collected on the first and last day of each intervention period to
      assess immune function. A final stool sample will be obtained in the last week of the
      intervention period. Nutritional status, which can impact immune function, will be assessed
      using the Mini-Nutritional Assessment, Block Fiber Screen, and the Block 2005 Food Frequency
      Questionnaire. Daily questionnaires will record intake of the probiotic or placebo, level of
      stress, hours of sleep, visits to the physician, new medications, number of stools, etc. The
      Gastrointestinal Symptom Response Scale, which records gastrointestinal symptoms, such as
      bloating, gas, diarrhea, and constipation, over the past week will be completed at baseline
      and weekly during the interventions and the week following the interventions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in cytokine production
time frame: Measured at baseline and after 3 weeks of supplementation for each arm
description: Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation
measure: Change in bacterial species measured in fecal samples
time frame: Measured at baseline and after 3 weeks of supplementation for each arm
description: Microbial diversity measured by 454 16S rRNA sequence analysis
qPCR to quantify changes in bacteria of interest
measure: Change in digestive symptoms on the Gastrointestinal Symptom Response Scale
time frame: Measured at baseline, weeks 1, 2, 3 and 4 of each arm
description: Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale
measure: Change in Mucosal immune function
time frame: Measured at baseline and after 3 weeks of supplementation for each arm
description: sIgA
arm group label: Probiotic
arm group type: Experimental
description: Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsules containing placebo
intervention type: Dietary Supplement
intervention name: Probiotic
description: 2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)
arm group label: Probiotic
intervention type: Dietary Supplement
intervention name: Placebo
description: 2 capsules daily containing 348.25 mg of potato starch
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bobbi Langkamp-Henken, PhD, RD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor