Trial Information

Pilot Study of the Fecal Microbiome in the Shanghai Population

To examine how risk for colorectal cancer (CRC) is related to the microbes that inhabit the
distal human intestine (the microbiota), we have proposed a large study that compares
characteristics of the fecal microbiota in CRC patients and controls in the Shanghai
population. In advance of that, we are proposing a small pilot study with the following two
objectives: 1) determine participation rates among Shanghai adults, age 50-74 who are
positive by fecal immunochemical test (FIT+); and 2) determine the suitability of fecal
specimens provided by the participants for microbiome analyses. Each of two Shanghai
community health centers, where CRC screening is ongoing, will recruit 25 FITplus
participants (half male; half age 50-64, half age 65-74). Each of the 50 participants will
provide informed consent, brief questionnaire data, blood plasma and buffy coar, a urine
specimen, and four samples of one stool, which will be frozen. Complete blood count and
plasma glucose, cholesterol, and creatinine levels will be determined in real time and
returned to the participant. Each participant's plasma, buffy coat, urine, and one pair of
fecal samples will be stored frozen for future genetic or other assays. DNA will be
extracted from the second pair of fecal samples from each participant (n equals100 vials),
amplified for 16S rRNA genes, and sequenced to determine fecal microbiome profiles.
Participation will be deemed unsatisfactory if participation is < 30% overall (95%
confidence interval 17% - 43% for N=50 participants), or if there are < 20 male, female,
younger, or older participants. Specimen quality will be deemed unsatisfactory if the
intraclass correlation coefficient (ICC) is < 0.70 (95% confidence interval 0.53 - 0.82 for
N=50 paired vials) for the Shannon index estimate of microbiome alpha diversity.