Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer

Colorectal Cancer Clinical Trial

— METS  

Official title:

Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780284
• Other study ID #: AAAP1611
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study has 2 aims:

Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.

Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.

Description:

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Fluent in English or Spanish;

2. At high risk of developing colorectal cancer;

3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);

4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics

5. Access to either smart phone or computer; and

6. Currently physically inactive.

Exclusion Criteria:

Any criterion not met under inclusion.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Physical activity intervention
150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants retained at the end of study	To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial	8 weeks
Secondary	Percentage of participants with collected, processed, and analyzed stool samples	To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data	8 weeks