InfluenzaPhase 1NCT01304771
Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly
A Phase 1 study testing Synbiotic AKSB in people with Influenza, run by Mayo Clinic at 1 site in United States.
Trial summary
Probiotics are viable commensal microorganisms that promote the establishment of beneficial microflora. Animal and human studies demonstrate that probiotics can enhance body's immune response to stimuli. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Synbiotic AKSB
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Persons, male and female, 65 years of age and older.
- Eligible and willing to receive the influenza vaccine and take the study drug.
- Not currently on immunosuppressive drugs such as chemotherapy, oral or parenteral prednisone or Tumor Necrosis Factor-alpha (TNF-α) inhibitor therapy.
- Not allergic to chicken/egg protein.
- Willing to have blood drawn (4 times) during the study.
- Willing to complete a simple diary documenting toxicity, pill count and any side effects of the medication and any reported illnesses during this period.
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- Willingness to take 4 capsules per day, keep a symptom and capsule diary, and return these materials to the clinic at the conclusion of the study.
- Willingness to avoid all over the counter nutritional supplements, probiotics, and yogurts containing probiotics during the duration of the study.
- Patients who have provided their written informed consent prior to participation in the study and have signed and dated an appropriate Health Insurance Portability and Accountability Act (HIPAA) authorization form.
- Blood laboratory results within the 7 days of starting study drug
- Normal liver function as shown by:
- serum AST within upper limits of normal
- Adequate renal function as shown by :
- serum creatinine ≤ 2.0 mg/dL
- Hemoglobin > 11gm/dL; WBC: > 3.5X109 /L and platelets > 100 X 109 /L
Who cannot join
- Antibiotic use - current or within 2 weeks prior to start of the study.
- Chicken/Egg hypersensitivity or hypersensitivity to influenza vaccine components such as bactopeptone, beta-propiolactone, neomycin, gentamicin, monosodium glutamate, formaldehyde or formalin, gelatin, polyethylene glycol p-iso-octylphenyl ether (Triton X-100), polymyxin B, polyoxyethylene 9-10 nonyl phenol (Triton N-101, octoxynol 9), or thimerosal.
- Talc allergy
- Influenza vaccine within the prior 12 months.
- Immunosuppressed status either from illness such as acquired immunodeficiency syndrome (AIDS), or with concomitant chemotherapy, or iatrogenic immunosuppression such as prednisone or other drugs such as TNF-α inhibitor therapy.
- History of known serious illness such as active cancer (except localized skin or non-metastatic prostate cancer), poorly controlled congestive heart failure, poorly controlled diabetes, acute or progressive renal or hepatic failure, chronic obstructive lung disease requiring oxygen.
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- Ongoing anti-influenza therapy with amantadine, rimantadine, oseltamivir or zanamivir
- Active or recent (within last 6 months) history consistent with acute influenza illness. Febrile illness with headache, sore throat and temperature more than 37.5C on the day of enrollment.
- Known chronic inflammatory bowel disease such as Crohn's disease, active bowel cancer (defined as being on chemotherapy or having an untreated bowel cancer)
- Hypersensitivity to any components of the AKSB, placebo or the vaccine.
- Oral typhoid vaccine use in the last 2 weeks.
- Patients who have participated in a clinical study and/or received any investigational medication during the last month (30 days) preceding study Day 1; or currently enrolled in an investigational study.
- Patients who, in the opinion of the investigator, possess insufficient mental or reading ability that prevents their understanding and providing informed consent and appropriate HIPAA authorization;
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
- Patients who are unwilling or unable to comply with the study protocol for any other reason.
- History of Guillain-Barré Syndrome within 6 weeks following a previous dose of the inactivated vaccine.
- Allergy or contraindication to two or more of the following: vancomycin, penicillins, daptomycin, linezolid
- Allergy or contraindication to two or more of the following: fluconazole, deoxycholate amphotericin B, liposomal amphotericin B, itraconazole or voriconazole
- Blood laboratory results within the 7 days of starting study drug
- Abnormal normal liver function as shown by:
- serum AST above the upper limits of normal
- Impaired renal function as shown by :
- i. serum creatinine > 2.1 mg/dL
- Hemoglobin < 11gm/dL; WBC: < 3.5X109 /L and platelets < 100 X 109 /L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial of the Safety and Efficacy of Adjuvant AKSB (Agri-King Synbiotic) Synbiotic in Patients 65 Years of Age and Older Receiving the Influenza Vaccine
Probiotics are viable commensal microorganisms that promote the establishment of beneficial microflora. Animal and human studies demonstrate that probiotics can enhance body's immune response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide [FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human volunteers, over 65 years of age, is designed to study the safety of this probiotic when patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then our aim is to do a larger study to see if we can improve influenza vaccine immune response while taking the probiotic compared to placebo.
- Conditions
- Influenza
- Being tested
- Synbiotic AKSB
- Keywords
- Safety, AKSB, probiotic, synbiotic, enterococcus, Saccharomyces, elderly, influenza, vaccine, immune, response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic AKSBBiological
AKSB is a novel synbiotic that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide [FOS], NutraFlora®).
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic AKSB | Active comparator | Participants (healthy > 65 year old persons) will be randomized to take the synbiotic AKSB. All participants will also receive inactivated trivalent Influenza vaccine while being on the AKSB. We will assess safety of the AKSB in this setting. We will also assess the stool microbiology in relation to vancomycin-resistant enterococcus and probiotic strain enterococcus. We will also assess influenza vaccine response in patients on AKSB Receives: Biological: Synbiotic AKSB |
| Talc Placebo | Placebo comparator | Participants (healthy > 65 year old persons) will be randomized to take the placebo. All participants will also receive inactivated trivalent Influenza vaccine while being on the placebo. We will also assess the stool microbiology in relation to vancomycin-resistant enterococcus. We will also assess influenza vaccine response in patients on placebo. Receives: Biological: Synbiotic AKSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse events
To evaluate the safety and tolerability of AKSB when administered with the influenza vaccine as compared to the influenza vaccine alone with placebo in patients ≥65 years of age.
Measured: 127 days
Secondary outcomes (2)
Compare stool presence of probiotic enterococcal strain
To evaluate for stool VRE presence pre-post intervention and to compare molecular fingerprinting of VRE isolated with the SF68 strain of enterococci used in the study drug to demonstrate safety of the study drug.
Measured: baseline to 21 days
Immune response to Influenza A vaccine in the AKSB arm compare to Placebo
To determine whether AKSB can increase the protection rate [PR, (number of participants that achieve the protective antibody titer)] by 20% in the AKSB arm at days 14, 28 days and 120 days after vaccination among the elderly patients (≥ 65 years of age). Effect of age (65-75 years and >75 years), gender, underlying medical history and previous vaccination status (within the last 2 years) will evaluated.
Measured: days 14, 28 days and 120 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Abinash Virk, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304771
- Sponsor's protocol ID
- 10-001923
- Other IDs
- R21AT002708-01A1
- Status last verified
- Jun 2012
- First submitted
- 3 Dec 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Safety and Efficacy of Adjuvant AKSB (Agri-King Synbiotic) Synbiotic in Patients 65 Years of Age and Older Receiving the Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01304771
- Acronym / sponsor ID
- 10-001923
- Conditions
- Influenza
- Keywords
- Safety, AKSB, probiotic, synbiotic, enterococcus, Saccharomyces, elderly, influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Feb 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.
Probiotics are viable commensal microorganisms that promote the establishment of beneficial microflora. Animal and human studies demonstrate that probiotics can enhance body's immune response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide [FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human volunteers, over 65 years of age, is designed to study the safety of this probiotic when patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then our aim is to do a larger study to see if we can improve influenza vaccine immune response while taking the probiotic compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic AKSB | Active comparator | Biological: Synbiotic AKSBParticipants (healthy > 65 year old persons) will be randomized to take the synbiotic AKSB. All participants will also receive inactivated trivalent Influenza vaccine while being on the AKSB. We will assess safety of the AKSB in this setting. We will also assess the stool microbiology in relation to vancomycin-resistant enterococcus and probiotic strain enterococcus. We will also assess influenza vaccine response in patients on AKSB |
| Talc Placebo | Placebo comparator | Biological: Synbiotic AKSBParticipants (healthy > 65 year old persons) will be randomized to take the placebo. All participants will also receive inactivated trivalent Influenza vaccine while being on the placebo. We will also assess the stool microbiology in relation to vancomycin-resistant enterococcus. We will also assess influenza vaccine response in patients on placebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Persons, male and female, 65 years of age and older.
- Eligible and willing to receive the influenza vaccine and take the study drug.
- Not currently on immunosuppressive drugs such as chemotherapy, oral or parenteral prednisone or Tumor Necrosis Factor-alpha (TNF-α) inhibitor therapy.
- Not allergic to chicken/egg protein.
- Willing to have blood drawn (4 times) during the study.
Key exclusion criteria (24 listed)
- Antibiotic use - current or within 2 weeks prior to start of the study.
- Chicken/Egg hypersensitivity or hypersensitivity to influenza vaccine components such as bactopeptone, beta-propiolactone, neomycin, gentamicin, monosodium glutamate, formaldehyde or formalin, gelatin, polyethylene glycol p-iso-octylphenyl ether (Triton X-100), polymyxin B, polyoxyethylene 9-10 nonyl phenol (Triton N-101, octoxynol 9), or thimerosal.
- Talc allergy
- Influenza vaccine within the prior 12 months.
- Immunosuppressed status either from illness such as acquired immunodeficiency syndrome (AIDS), or with concomitant chemotherapy, or iatrogenic immunosuppression such as prednisone or other drugs such as TNF-α inhibitor therapy.
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 |
|---|---|---|
| Synbiotic AKSBAKSB is a novel synbiotic that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide [FOS], NutraFlora®). | Biological | Synbiotic AKSB, Talc Placebo |
Primary outcome
number of patients with adverse events
Time frame: 127 days
To evaluate the safety and tolerability of AKSB when administered with the influenza vaccine as compared to the influenza vaccine alone with placebo in patients ≥65 years of age.
2 secondary outcomes
Compare stool presence of probiotic enterococcal strain
Time frame: baseline to 21 days
Immune response to Influenza A vaccine in the AKSB arm compare to Placebo
Time frame: days 14, 28 days and 120 days after vaccination
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 20 Jun 2012.
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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.
Abinash Virk, MD principal investigator
Mayo Clinic
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 Synbiotic AKSB in people with Influenza, run by Mayo Clinic 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 15 inclusion and 24 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 20 Jun 2012. 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?
number of patients with adverse events (time frame: 127 days). 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 20 Jun 2012.