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Completed

NCT Number: NCT03297996

Study of Gut Microbiome and Colorectal Tumors

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.

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Key information

Conditions

Serrated Polyp Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hyperplastic Polyp Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Sessile Serrated Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobio PowerSoil DNA Isolation Kit

Diagnostic Test

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

Primary outcomes

  1. Prevalence and relative abundance of selected fecal microbial taxa

    Time frame: 2 Days

    Quantitative polymerase chain reaction

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2017
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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