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Probiotics (L. Gasseri, B. Bifidum, B. Longum) on Immune and Intestinal Health in Healthy Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01662206
First received: July 26, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Dietary Supplement: Probiotic
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Probiotics (Lactobacillus Gasseri, Bifidobacterium Bifidum, Bifidobacterium Longum) on Immune and Intestinal Health in Healthy Older Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in cytokine production [ Time Frame: Measured at baseline and after 3 weeks of supplementation for each arm ] [ Designated as safety issue: No ]
    Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation

  • Change in bacterial species measured in fecal samples [ Time Frame: Measured at baseline and after 3 weeks of supplementation for each arm ] [ Designated as safety issue: No ]
    • Microbial diversity measured by 454 16S rRNA sequence analysis
    • qPCR to quantify changes in bacteria of interest


Secondary Outcome Measures:
  • Change in digestive symptoms on the Gastrointestinal Symptom Response Scale [ Time Frame: Measured at baseline, weeks 1, 2, 3 and 4 of each arm ] [ Designated as safety issue: No ]
    Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale

  • Change in Mucosal immune function [ Time Frame: Measured at baseline and after 3 weeks of supplementation for each arm ] [ Designated as safety issue: No ]
    sIgA


Enrollment: 46
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum
 Dietary Supplement: Probiotic
2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)
Placebo Comparator: Placebo
Capsules containing placebo
 Dietary Supplement: Placebo
2 capsules daily containing 348.25 mg of potato starch

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 to 80 years of age.
  • willing and able to complete the Informed Consent Form in English
  • willing to provide demographic information (age, race)
  • willing and able to complete daily and weekly questionnaires regarding general wellness, bowel function and gastrointestinal symptoms.
  • willing to provide 4 blood, 4 stool, and 4 saliva samples
  • willing to discontinue any immune-enhancing dietary supplements ( e.g., prebiotics supplements, Echinacea, fish oil, vitamin E >200% of the RDA).
  • able to take the study probiotic without the aid of another person.

Exclusion Criteria:

  • not meet the above criteria.
  • taking any medication for constipation or diarrhea.
  • currently taking any anti-inflammatory drugs on a regular basis.
  • current smoker.
  • typically consume fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
  • currently being treated for or have any of the following physician- diagnosed diseases or conditions: HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), kidney disease, diabetes or gastrointestinal disease or conditions (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than GERD or diverticular disease or have a central venous catheter.
  • received chemotherapy or other immune suppressing therapy within the last year.
  • received antibiotic therapy in the past two months.
  • cannot schedule planned immunizations to at least 4 weeks before the start of the study, in the week following the second blood draw, or after the 4th blood draw.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662206

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01662206     History of Changes
Other Study ID Numbers: 236-2012, 236-2012
Study First Received: July 26, 2012
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
adults
probiotics
immune function
microbiota
digestive health

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

ClinicalTrials.gov processed this record on June 17, 2013