DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

A -- USE OF HUMAN FLORA-ASSOCIATED MICE TO STUDY THE EFFECT OF LOW DOSES OF AN ANTIMICROBIAL SOL 223-00-7201 DUE 062700 POC Susan Gane, Contracting Officer, (301)-827-7166 WEB: http://www/FDA.gov/OC/OFACS/Contracts, http://www/FDA.gov/OC/OFACS/Contracts. E-MAIL: sgane@OC.FDA.gov, sgane@OC.FDA.gov. A Use of Human Flora Associated Rodents to Study the Effect of Low Doses of an Antimicrobial. The Center for Veterinary Medicine of the Food and Drug Administration has a requirement for a one-year study to determine the concentration of a fluoroquinolone antibiotic, ciprofloxacin, that produces no adverse effect in the human flora-associated mice model. The endpoints or parameters to be evaluated include: 1) changes in the metabolic activity of the fecal flora (fecal pH; bacterial proteins; reductive and hydrolytic enzyme activities, concentration of short chain fatty acids, and profile of cellular fatty acids; 2) development of antimicrobial resistant strains; 3) disruption of colonization resistance to a pathogenic microorganism; and 4) counts of target organisms (aerobes and anaerobes). The fecal suspension used to inoculate the rodents will originate from healthy volunteer(s) not treated with antibiotics for at least 3 months. Posted 04/25/00 (W-SN448350). (0116)

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