Clinical trial · Observational
Role of Diet on the Microbiome of the Digestive System
The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study
NCT04666727CI-TRIAL-00112572recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Dietary patterns
- timeFrame
- Baseline
- description
- Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
- measure
- Microbiome composition
- timeFrame
- Baseline
- description
- 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.
- measure
- Somatic mutation burden
- timeFrame
- Baseline
- description
- Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.