Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly

Inclusion criteria

• 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.
• 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

Exclusion criteria

• 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.
• 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