Adults on Antibiotics
Conditions
Keywords
Probiotics, BB-12, Yogurt, Antibiotics
Brief summary
We believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food. More specifically, the rationale for this Phase I study is to determine safety of our drink and comply with the FDA's recommendations pertaining to an IND application, we will conduct a phase I safety study. We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
Interventions
DRUGBifidobacterium animalis subsp. lactis strain BB-12
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
DRUGPlacebo
Strawberry flavored yogurt
Sponsors
Medstar Health Research Institute
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to speak and write English or Spanish * Refrigerator for proper storage of drink * Telephone access * Enrollment must take place within 24 hours of starting antibiotics * Treatment with a penicillin class antibiotic regimen for 10 days for an upper respiratory infection; The following is a list of inclusive antibiotics: 1. Amoxicillin 2. Augmentin (amoxicillin/clavulanate) 3. Ancef (cefazolin) 4. Cefadroxil 5. Cephalexin 6. Cephradine 7. Duricef (cefadroxil) 8. Keflex (cephalexin) 9. Kefzol (cefazolin) 10. Velosef (cephradine) 11. Ceclor (cefaclor) 12. Cefotan 13. Cefoxitin 14. Ceftin (cefuroxime) 15. Cefzil (cefprozil) 16. Lorabid (loracarbef) 17. Mefoxin (Cefoxitin) 18. Zinacef (cefuroxime) 19. Omnicef (cefdinir) 20. Suprax (cefixime) 21. Dicloxacillin 22. Pen-Vee K (penicillin) * Antibiotic prescribed at least twice a day * Outpatients
Exclusion criteria
* Chronic conditions, such as diabetes or asthma, that require daily medication * Allergy to strawberry * Active diarrhea * Allergy to penicillin class antibiotic * Any other medicines used except prescribed antibiotic and anti-pyretic medicines * Allergy to any of the following medications 1. Tetracycline 2. Erythromycin 3. Trimethoprim 4. Ciprofloxacin * Lactose intolerance. * During baseline physical exam, any of the following will be grounds for exclusion; systolic blood pressure\>140, systolic blood pressure \<90, diastolic \>90, oxygen saturation \<98%, pulse rate \>100, pulse rate \<55 and respiratory rate \>17. These include all vital signs that fall outside of the normal range, including Grade 1 through Grade 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy adults who are consuming antibiotics. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| In addition to safety diary, participants will keep a daily diary to track number of bowel movements, if drink was consumed, if illness resulted in change in activity, over-the-counter medicines used and other illness symptoms. | 1 year |
Countries
United States
Outcome results
None listed