HealthyPhase 1NCT01368029
Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
A Phase 1 study testing Lactobacillus rhamnosus GG ATCC 53103 (LGG) in people with Healthy and Elderly, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Lactobacillus rhamnosus GG ATCC 53103 (LGG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 1
- 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
- Age 65-80 years
- Willing to complete the informed consent process
- Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
- Is community dwelling for the past two years
- Has received routine physical in the past two years
- Has no new chronic conditions in the past two years
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- Identifies a primary care clinician
- Has received recommended preventive services (Task Force for Clinical Preventive Services) for vaccination and cancer prevention/detection, e.g.:
- Pneumococcal vaccination
- Mammography
- Screening colonoscopy for cancer
- Willing to comply with protocol and report on compliance and side effects during the study period
- Informed consent obtained and signed prior to screening
Who cannot join
- Self-reported vaccination with influenza vaccine for the current season
- Vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period
- History of hypersensitivity to any influenza vaccine components including thimerosal or egg
- History of Guillain-Barre syndrome
- History of avoidance of egg and/or egg based products for any reason
- Acute febrile illness within the week prior to immunization - immunization deferred until illness resolved
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- Consumption of supplements or food products containing LGG or probiotics for 28 days prior to the start of the study or consumption of yogurt that has the "live and active cultures" seal
- Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or antibiotics that may be used to treat LGG bacteremia or infection
- Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on the day of enrollment
- Drug or alcohol abuse within the previous 12 months
- Hospitalization, major surgery or endoscopy within the last 3 months
- Scheduled hospital admission within 3 months of enrollment
- Resident of a nursing home or rehabilitation center
- Presence of any of the following:
- Grade 2 or higher abnormal vital signs or abnormalities on physical exam
- Indwelling catheter or implanted hardware/prosthetic device or feeding tube
- Current or within the last 2 years, any episode of bowel leak, acute abdomen, diverticulitis, bloody bowel movements or peptic ulcer disease, including any surgical procedure or current prescription medications for any of these conditions
- Current or within the last 4 weeks, active bowel disease such as an episode of infectious or non-infectious diarrhea, constipation or vomiting lasting more than 12 hours or current prescription medications for any of these conditions
- Any history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, history of disease or current prescription medication for any of these conditions
- Any history of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease
- Underlying structural heart disease such as abnormal native heart valve replacement, Stage IV congestive heart failure
- History of peripheral vascular disease or stroke
- Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm^3 or active or planned chemotherapy or radiotherapy
- History of collagen vascular or autoimmune disease
- End stage renal disease
- History of chronic obstructive pulmonary disease or asthma
- Diabetes or thyroid disease
- Active tuberculosis (TB), defined as undergoing a work up for suspected active TB infection or currently on treatment for active TB
- Positive drug or alcohol testing at screening or positive breathalyzer at baseline or an unwillingness to undergo drug and alcohol testing
- Abnormal laboratory tests defined as any of the following:
- White blood cell (WBC) <3.3 or > 12.0 K/microliter
- Platelets < 125 K/microliter
- Hemoglobin Males: < 12.0 g/dL; Females < 11.0 g/dL
- Creatinine > 1.8 mg/dL
- Blood Urea Nitrogen (BUN)> 27 mg/dL
- Aspartate aminotransferase (AST) > 1.25 ULN
- Alanine aminotransferase > 1.25 ULN
- Alkaline phosphatase > 2.0 ULN
- Bilirubin (total) > 1.5 ULN
- Glucose (nonfasting) > 126 mg/dL
- Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Double Blind Randomized Controlled Trial to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are:
- LGG or placebo administered twice daily will be safe and well tolerated in elderly subjects who have just received the trivalent inactivated influenza vaccine
- The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the influenza season will be higher in the LGG group than the placebo group
- The occurrence rate of influenza like illness during the influenza season will be lower in the LGG group than in the placebo group
- The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56 and at the end of the influenza season will be greater in the LGG group than the placebo group.
- Being tested
- Lactobacillus rhamnosus GG ATCC 53103 (LGG), Placebo
- Keywords
- LGG, Immune response, Influenza vaccine, Elderly, Healthy, Microbiome
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GG ATCC 53103 (LGG)Biological
Also called Culturelle, LGG
Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days
PlaceboBiological
Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| LGG | Experimental | Lactobacillus rhamnosus GG (LGG) containing 1x10^10 LGG per capsule will be given to volunteers with verbal and written instructions at the baseline visit. Capsules are to be taken orally twice a day on an outpatient basis. Receives: Biological: Lactobacillus rhamnosus GG ATCC 53103 (LGG) |
| Placebo | Placebo comparator | Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events that are possibly or probably related to administration of LGG
Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires. Additionally, subjects are encouraged to call the PI or study staff at any time if they are experiencing an adverse event.
Measured: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Secondary outcomes (4)
Anti-influenza systemic immune response
HAI, MN titers and IgA titers will be measured at days 21, 28, 56 and the end of the influenza season
Measured: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Anti-influenza mucosal immune response
IgA titers will be measured at days 21, 28, 56 and at the end of the influenza season
Measured: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Occurrence of influenza like illness
Influenza like illness is defined as a reported oral temperature of 100 degrees Fahrenheit with at least 2 symptoms of acute respiratory illness
Measured: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture
Stool and nasopharyngeal specimens will be analyzed to learn what bacteria are present during different phases of the study and how the types and quantities of bacteria may change over time
Measured: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 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 Massachusetts General HospitalThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia L. Hibberd, Massachusetts General Hospital
- Investigators
- Patricia L. Hibberd, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368029
- Sponsor's protocol ID
- 2010 P 001694
- Status last verified
- Jan 2017
- First submitted
- 2 Jun 2011
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Trial to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01368029
- Acronym / sponsor ID
- 2010 P 001694
- Keywords
- LGG, Immune response, Influenza vaccine, Elderly, Healthy, Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Jun 2011 (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.
This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are:
- LGG or placebo administered twice daily will be safe and well tolerated in elderly subjects who have just received the trivalent inactivated influenza vaccine
- The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the influenza season will be higher in the LGG group than the placebo group
- The occurrence rate of influenza like illness during the influenza season will be lower in the LGG group than in the placebo group
- The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56 and at the end of the influenza season will be greater in the LGG group than the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG | Experimental | Biological: Lactobacillus rhamnosus GG ATCC 53103 (LGG)Lactobacillus rhamnosus GG (LGG) containing 1x10^10 LGG per capsule will be given to volunteers with verbal and written instructions at the baseline visit. Capsules are to be taken orally twice a day on an outpatient basis. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age 65-80 years
- Willing to complete the informed consent process
- Able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
- Is community dwelling for the past two years
- Has received routine physical in the past two years
Key exclusion criteria (43 listed)
- Self-reported vaccination with influenza vaccine for the current season
- Vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period
- History of hypersensitivity to any influenza vaccine components including thimerosal or egg
- History of Guillain-Barre syndrome
- History of avoidance of egg and/or egg based products for any reason
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 |
|---|---|---|
| Lactobacillus rhamnosus GG ATCC 53103 (LGG)Also: Culturelle, LGGStudy drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days | Biological | LGG |
| PlaceboPlacebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days. | Biological | Placebo |
Primary outcome
Occurrence of adverse events that are possibly or probably related to administration of LGG
Time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires. Additionally, subjects are encouraged to call the PI or study staff at any time if they are experiencing an adverse event.
4 secondary outcomes
Anti-influenza systemic immune response
Time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Anti-influenza mucosal immune response
Time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Occurrence of influenza like illness
Time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture
Time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.
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 11 Jan 2017.
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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.
Patricia L. Hibberd, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus rhamnosus GG ATCC 53103 (LGG) in people with Healthy and Elderly, run by Massachusetts General Hospital 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 13 inclusion and 43 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 11 Jan 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Occurrence of adverse events that are possibly or probably related to administration of LGG (time frame: Subjects will be followed from the study start through the end of the influenza season (as defined by CDC) with an anticipated average for most subjects of 7 months.). 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 11 Jan 2017.