Study Type: Intervention

Expected Total Enrollment:

Study Dates: -

The purpose of this study is to describe the intestinal microbiomes of a cohort of healthy adult subjects over a 6-month period of time. Many questions about the human microbiota exist. Previous studies have shown that the differences among individuals are greater than the differences among different sampling sites in a single individual. Up to 60 healthy adult subjects, ages 18-45 years, from the Baltimore and University of Maryland Baltimore communities will be recruited and screened to document their health status. A brief medical history, including recent travel and antibiotic use, will be recorded. Subjects will provide a stool specimen for genomic analysis of the intestinal microbiome over a 6-month period at the following intervals: Day 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 13, Week 14, Week 15, Week 16, Week 20, and Week 24. At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every12 hours. Weekly stool specimens will be obtained beginning with the first day of antibiotic use and for 4 Weeks thereafter. Then monthly specimens of stool and other sites will be resumed at Week 16. The primary objective is to define the human intestinal microbiome in healthy adults in a longitudinal fashion. The secondary objective is to define the re-colonization of the intestine after treatment with a broad-spectrum antibiotic using comprehensive genomic techniques. Each subject will participate in the study for up to 7 months.

Inclusion Criteria:

Male or female, age 18-45 years, inclusive.

Healthy as determined by screening medical history, medication history, and absence
of acute illness such as gastrointestinal or respiratory infection.

Capable of understanding, consenting and complying with the entire study protocol.

Provide voluntary written Informed Consent.

Females of childbearing potential are required to utilize an appropriate method of
contraception [abstinence, oral contraceptives, IUD, condoms with spermicidal foam,
surgical sterilization depots and injectable contraceptives, or diaphragms with
spermicidal jelly or cream] 30 days prior to the Week 12 visit.

Exclusion Criteria:

Chronic diarrhea, inflammatory bowel disease, irritable bowel syndrome, or other
gastrointestinal disorder, gastrointestinal surgery (except appendectomy,
polypectomy, or herniorraphy), or severe chronic illness such as major organ failure,
diabetes, HIV/AIDS.

Female who is pregnant or lactating; or a female subject with a positive urine
pregnancy test determined at the Week 12 visit.

History of hypersensitivity to Ciprofloxacin, any member of the quinolone class of
antimicrobial agents, or any compound of the product.

History of tendinitis or tendon rupture.

History of seizures other than febrile seizure as a young child.

Treatment with antibiotics within one month before the initial specimen collection.

History of clinically significant acute or chronic illness or other condition
requiring chronic medication therapy (including systemic but not intranasal
steroids), except for birth control pills, inhalers, anti-anxiety or anti-depression
medications.

History of cardiac rhythm abnormalities or QT prolongation or a family history of
cardiac rhythm abnormalities or sudden unexplained death.

History of current or past use of theophylline for asthma or tizanidine, due to known
interaction with Ciprofloxacin.

History of spasticity (due to the potential for requiring tizanidine treatment),
asthma, chronic bronchitis, emphysema, and other lung diseases (due to potential for
requiring theophylline [or dimethylxanthine] treatment).

Medical, occupational, or family problems as a result of alcohol or illicit drug use
during the past 12 months.