Status:
COMPLETED
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Medstar Health Research Institute
Conditions:
Adults on Antibiotics
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 im...
Eligibility Criteria
Inclusion
- 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:
- Amoxicillin
- Augmentin (amoxicillin/clavulanate)
- Ancef (cefazolin)
- Cefadroxil
- Cephalexin
- Cephradine
- Duricef (cefadroxil)
- Keflex (cephalexin)
- Kefzol (cefazolin)
- Velosef (cephradine)
- Ceclor (cefaclor)
- Cefotan
- Cefoxitin
- Ceftin (cefuroxime)
- Cefzil (cefprozil)
- Lorabid (loracarbef)
- Mefoxin (Cefoxitin)
- Zinacef (cefuroxime)
- Omnicef (cefdinir)
- Suprax (cefixime)
- Dicloxacillin
- Pen-Vee K (penicillin)
- Antibiotic prescribed at least twice a day
- Outpatients
Exclusion
- 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
- Tetracycline
- Erythromycin
- Trimethoprim
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00848003
Start Date
October 1 2009
End Date
July 1 2011
Last Update
May 20 2013
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007