Longitudinal Study of the Human Intestinal Microbiome
The purpose of this study is to identify the human intestinal microbiota (microbes that live inside and on human bodies) in healthy adults over a 6-month period and to study the effect of an antibiotic on the intestinal microbiota. Participants will include up to 60 healthy adult subjects, ages 18-45 years, from the Baltimore and University of Maryland communities. Study procedures will include providing multiple stool samples throughout the study. Participants will take a licensed antibiotic, Ciprofloxacin, for 3 days. Participants may be involved in study related procedures for up to 7 months.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Longitudinal Study of the Human Intestinal Microbiome Before and After Antibiotic Administration|
- Isolation of Genomic DNA from stool samples. [ Time Frame: Weekly stool samples will be obtained for over a 6-month period at the following intervals: Day 0, Weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16, 20, and 24. ] [ Designated as safety issue: No ]
- Analysis of GI microbial community composition using the Affymetrix PhyloChip Platform. [ Time Frame: Analysis. ] [ Designated as safety issue: No ]
- Surveys of GI microbiome diversity using 16S rDNA analysis at the Institute of Genome Sciences. [ Time Frame: Analysis. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
At Week 12, subjects will receive a 3-day course of oral Ciprofloxacin 500 mg every 12h.
Drug: Ciprofloxacin hydrochloride
Licensed medication, dose: 500 mg every 12 hours for 3 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832286
|United States, Maryland|
|University of Maryland School of Medicine - Center for Vaccine Development - Baltimore|
|Baltimore, Maryland, United States, 21201|