Study of Gut Microbiome and Colorectal Tumors

Completed

• Conditions: Sessile Serrated Adenoma; Serrated Polyp; Hyperplastic Polyp; Colorectal Cancer
• Interventions: Diagnostic Test: Mobio PowerSoil DNA Isolation Kit

• Registration Number: NCT03297996
• Lead Sponsor: NYU Langone Health

Brief Summary

Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing of stool samples. Investigators compared gut microbiota diversity, overall composition, and normalized taxon abundance among these groups.

Detailed Description

Colorectal cancer is a heterogeneous disease arising from at least two precursors-the conventional adenoma (CA) and the serrated polyp. A relationship between the human gut microbiota and colorectal cancer has been shown; however, its relationship to the different early precursors of colorectal cancer is understudied. This study tested, for the first time, the relationship of the gut microbiota to specific colorectal polyp types.

Study Timeline

• Study Start: 2011-11-23
• Primary Completion: 2015-04-25
• Study Completion: 2015-04-25
• Status Verified: 2017-09
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-28
• Last Update Submitted: 2017-09-28
• Study First Posted: 2017-09-29
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Both men and women who have visited a gastroenterologist or surgeon, aged 18 or older will be included in this study.
• Both men and women residents in the United States, aged 18 or older will be included in this study.

Read More

Exclusion Criteria

• Women who are pregnant will be excluded from participating in this study
• Subjects on ongoing antibiotic therapy will be excluded from participating in this study.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NYU	Mobio PowerSoil DNA Isolation Kit	New York University (NYU) Human Microbiome and Colorectal Tumor study
SIT	Mobio PowerSoil DNA Isolation Kit	Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)

Primary Outcome Measures

Name	Time	Method
Prevalence and relative abundance of selected fecal microbial taxa	2 Days	Quantitative polymerase chain reaction

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States