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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:July 2012
End Date:October 2012
Contact:Bobbi Langkamp-Henken, PhD, RD
Email:henken@ufl.edu
Phone:352-392-1991

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Probiotics (Lactobacillus Gasseri, Bifidobacterium Bifidum, Bifidobacterium Longum) on Immune and Intestinal Health in Healthy Older Adults


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.

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.
We found this trial at
1
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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