Role of Diet on the Microbiome of the Digestive System | NCT04666727

Studies
Role of Diet on the Microbiome of the Digestive System

NCT04666727

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

May 26, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Colorectal Carcinoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2020Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the differences in dietary patterns among individuals reporting to be vegetarian and omnivorous.

II. To compare the difference in stool microbiome pattern in the above mentioned two groups of individuals.

III. To compare somatic mutations in colorectal epithelial cells in the above mentioned two groups of individuals.

SECONDARY OBJECTIVE:

I. To identify and characterize an association between diet, the microbiome and its genotoxic effect on the colorectal epithelial cells and predisposition to colorectal carcinogenesis.

OUTLINE:

Participants complete dietary questionnaire over 30-60 minutes and undergo collection of stool, blood, and tissue samples for analysis via sequencing and laser dissection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dietary patterns	Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.	Baseline
Microbiome composition	Will obtain estimates of microbiome composition from colonic mucosal biopsies in each group. Microbiome composition will be quantified using 16S profiling will be visualized across samples using stacked bar plots and principal coordinate analysis of the weighted Unifrac distances, and microbiome diversity within each sample will be quantified using the inverse-Simpson index.	Baseline
Somatic mutation burden	Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

GROUP I: Patients presenting for a screening colonoscopy
- GROUP I: Age of 45 and above
- GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)
- GROUP I: Non smoker
- GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples
- GROUP II: Patients presenting for a screening colonoscopy
- GROUP II: Age of 45 and above
- GROUP II: Omnivorous diet
- GROUP II: Non smoker
- GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample

Exclusion Criteria:

• Current smokers (nicotine abuse only)
- Positive family history of colon cancer or colon cancer related syndromes
- Recent use of antibiotics in 1 month
- History of inflammatory bowel disease, and/or radiation enteritis or colitis
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test
- Heavy drinker (defined as more than 14 drinks per week)
- Currently using anti-flatulence medications, probiotics and/or fiber supplements
- Major dietary restrictions and/or following a special diet
- Patient with positive fecal test/symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting for a screening colonoscopy at MD Anderson West Houston

Sampling Method

Non-Probability Sample

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site