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Study of Gut Microbiome and Colorectal Tumors

The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03297996
Enrollment
540
Registered
2017-09-29
Start date
2011-11-23
Completion date
2015-04-25
Last updated
2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Hyperplastic Polyp, Serrated Polyp, Sessile Serrated Adenoma

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.

Interventions

DIAGNOSTIC_TESTMobio 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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence and relative abundance of selected fecal microbial taxa2 DaysQuantitative polymerase chain reaction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026