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Completed

NCT Number: NCT01662206

Probiotics (L. Gasseri, B. Bifidum, B. 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.

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Key information

Conditions

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)

Placebo

Dietary Supplement

2 capsules daily containing 348.25 mg of potato starch

Primary outcomes

  1. Change in cytokine production

    Time frame: Measured at baseline and after 3 weeks of supplementation for each arm

    Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation

  2. Change in bacterial species measured in fecal samples

    Time frame: Measured at baseline and after 3 weeks of supplementation for each arm

    • Microbial diversity measured by 454 16S rRNA sequence analysis
    • qPCR to quantify changes in bacteria of interest

Secondary outcomes

  1. Change in digestive symptoms on the Gastrointestinal Symptom Response Scale

    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

  2. Change in Mucosal immune function

    Time frame: Measured at baseline and after 3 weeks of supplementation for each arm

    sIgA

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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