Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02371135

Enrollment

Registered

2015-02-25

Start date

2015-02-01

Completion date

2027-02-01

Last updated

2026-02-05

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

Conditions

Hereditary Colonic Polyposis Syndromes, Lynch Syndrome

Keywords

Gut Microbiome, 15-016

Brief summary

The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.

Interventions

GENETICcolonic biopsies

GENETICquestionnaires

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or Female age 18 or older * Hereditary colorectal cancer syndrome with one of the following: * Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes * Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)

Exclusion criteria

* Unable to provide informed consent for testing * Unable to complete English language questionnaire * Receiving active chemotherapy * Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy * No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy * No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

Design outcomes

Primary

Measure	Time frame	Description
association of the gut microbiome and dietary factors (To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses)	2 years	with risk of adenoma or cancer in Lynch syndrome and other hereditary colonic polyposis syndrome patients. To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORZsofia Stadler, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026