Analyzing gut microbiota in patients needing colonoscopy
"Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".
This study looks at the gut bacteria of people aged 50 to 75 who need a colonoscopy to see if certain bacteria patterns can help identify those at risk for colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT06174233 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients aged 50 to 75 who require a colonoscopy as part of routine care. It aims to analyze the gut microbiota of these patients to identify potential microbiota signatures associated with colorectal cancer and adenomas. Participants will complete questionnaires about their personal and family history, as well as dietary habits, while also undergoing routine FIT testing. The findings could lead to more targeted recommendations for follow-up colonoscopies based on microbiota profiles.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 75 who are scheduled for a colonoscopy and can provide a fecal sample.
Not a fit: Patients with known inflammatory bowel disease or those who have had a colectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance colorectal cancer screening by identifying individuals at higher risk based on their microbiota profiles.
How similar studies have performed: Other studies have shown promise in identifying microbiota signatures related to colorectal cancer, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 50 and 75 * Requiring colonoscopy * Able to provide a faecal sample and to perform a FIT test prior to colonoscopy * Without known inflammatory bowel disease (chronic inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC) and Crohn's disease (CD)) * No medical condition that, in the opinion of the investigator, should preclude inclusion in the study * Not having participated in any other clinical research study in which an investigational drug has been administered within 60 days prior to and including the date of informed consent or is likely to be administered during the period of colonoscopy * Participation agreement signed electronically Exclusion Criteria: * Persons not living in France (declaratory); * Persons subject to a protective measure, in particular guardianship or trusteeship, or unable to express their consent (declarative); * Persons who have had a colectomy (declaratory); * Person with a digestive stoma (declaration); * Person who did not sign the consent form; * Person who did not answer the entry questionnaire; * Person who did not send a compliant stool sample; * Antibiotics taken in the 3 months prior to inclusion (self-report); * Person aged under 50 or over 75.
Where this trial is running
Bobigny
- Hopital Avicenne, Centre de Recherche sur Volontaire — Bobigny, France (Recruiting)
Study contacts
- Principal investigator: ROBERT BENAMOUZIG, Pr — Aphp
- Study coordinator: ROBERT BENAMOUZIG, Pr
- Email: robert.benamouzig@aphp.fr
- Phone: 00148955434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.