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Food and Microbiome Longitudinal Investigation (FAMiLI)

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03293758
Collaborator
National Cancer Institute (NCI) (NIH)
10,000
Enrollment
1
Location
211.5
Anticipated Duration (Months)
47.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of human microbiome in health and disease. This study will serve as a critical NYU biorepository resource for research on human genetics and the microbiome in health and disease

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Food and Microbiome Longitudinal Investigation (FAMiLI)
    Actual Study Start Date :
    May 16, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2033

    Outcome Measures

    Primary Outcome Measures

    1. Demographic [5 Years]

      sex, race, education, oral health status, lifestyle, medical history, anthropometry, and medication use will be collected using the baseline questionnaire at enrolment. The collected information will provide risk stratification information for statistical control in studies of colorectal tumors and other major chronic diseases.

    Secondary Outcome Measures

    1. Differences in human microbiota between subjects with colorectal adenoma or colorectal cancer and those without. [5 Years]

      Pairwise alignment and clustering of sequences into operational taxonomic units (OTUs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age > 40
    Exclusion Criteria:

    • Use of long term antibiotics.

    • Pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jiyoung Ahn, PhD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03293758
    Other Study ID Numbers:
    • 12-00855
    • R21CA183887
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Feb 9, 2022