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

NCT01662206 | Completed

• 1 other identifier: 236-2012
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

adults; probiotics; immune function; microbiota; digestive health

Outcome Measures

Primary Outcomes (2)

• Change in cytokine production

  Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation

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

• Change in bacterial species measured in fecal samples

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

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

Secondary Outcomes (2)

• Change in digestive symptoms on the Gastrointestinal Symptom Response Scale

  Measured at baseline, weeks 1, 2, 3 and 4 of each arm

• Change in Mucosal immune function

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

Study Arms (2)

Probiotic

EXPERIMENTAL

Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Capsules containing placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

Placebo DIETARY_SUPPLEMENT

2 capsules daily containing 348.25 mg of potato starch

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 10, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (1)