Clinical trial · Interventional
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical activity intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Physical activity intervention
- description
- Subjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist.
- interventionNames
- Behavioral: Physical activity intervention
Primary outcomes (1)
- measure
- Percentage of participants retained at the end of study
- timeFrame
- 8 weeks
- description
- To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial
Secondary outcomes (1)
- measure
- Percentage of participants with collected, processed, and analyzed stool samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available