University of Florida
Gainesville, Florida, 32611, United States
NCT Number: NCT01662206
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.
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Notify Me65 year–80 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)
2 capsules daily containing 348.25 mg of potato starch
Time frame: Measured at baseline and after 3 weeks of supplementation for each arm
Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation
Time frame: Measured at baseline and after 3 weeks of supplementation for each arm
Time frame: Measured at baseline, weeks 1, 2, 3 and 4 of each arm
Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale
Time frame: Measured at baseline and after 3 weeks of supplementation for each arm
sIgA
University of Florida
Other
Probiotics (Lactobacillus Gasseri, Bifidobacterium Bifidum, Bifidobacterium Longum) on Immune and Intestinal Health in Healthy Older Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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