Study of Gut Microbiome and Colorectal Tumors

Colorectal Cancer Clinical Trial

Official title:

The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297996
• Other study ID #: 11-01377
• Status: Completed
• Phase: N/A
• First received: September 27, 2017
• Last updated: September 28, 2017
• Start date: November 23, 2011
• Est. completion date: April 25, 2015

Study information

• Verified date: September 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: April 25, 2015
• Est. primary completion date: April 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Hyperplasia
• Hyperplastic Polyp
• Polyps
• Serrated Polyp
• Sessile Serrated Adenoma

Intervention

Diagnostic Test:
• Mobio PowerSoil DNA Isolation Kit
16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and relative abundance of selected fecal microbial taxa	Quantitative polymerase chain reaction	2 Days