HealthyNCT01662206
Probiotics (L. Gasseri, B. Bifidum, B. Longum) on Immune and Intestinal Health in Healthy Older Adults
A study testing Probiotic in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)
PlaceboDietary supplement
2 capsules daily containing 348.25 mg of potato starch
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Capsules containing placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokine production
Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation
Measured: 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: 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
Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale
Measured: Measured at baseline, weeks 1, 2, 3 and 4 of each arm
Change in Mucosal immune function
sIgA
Measured: Measured at baseline and after 3 weeks of supplementation for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662206
- Sponsor's protocol ID
- 236-2012
- Other IDs
- 236-2012
- Status last verified
- Apr 2013
- First submitted
- 26 Jul 2012
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics (Lactobacillus Gasseri, Bifidobacterium Bifidum, Bifidobacterium Longum) on Immune and Intestinal Health in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01662206
- Acronym / sponsor ID
- 236-2012
- Conditions
- Healthy
- Keywords
- adults, probiotics, immune function, microbiota, digestive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticCapsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules containing placebo |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) | Dietary supplement | Probiotic |
| Placebo2 capsules daily containing 348.25 mg of potato starch | Dietary supplement | Placebo |
Primary outcome
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
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
2 secondary outcomes
Change in digestive symptoms on the Gastrointestinal Symptom Response Scale
Time frame: Measured at baseline, weeks 1, 2, 3 and 4 of each arm
Change in Mucosal immune function
Time frame: Measured at baseline and after 3 weeks of supplementation for each arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cytokine production (time frame: Measured at baseline and after 3 weeks of supplementation for each arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.