Investigating factors that influence polyp development in patients with Familial Adenomatous Polyposis
Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis
This study looks at how gut bacteria and environmental factors might affect polyp growth in people with Familial Adenomatous Polyposis who have had preventive surgery and regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon, France and 1 other locations) |
| Trial ID | NCT06614738 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the microbial and environmental factors that contribute to the development of polyps in individuals with Familial Adenomatous Polyposis (FAP). Participants will provide fecal and duodenal fluid samples to analyze the gut microbiota and its potential role in adenoma formation. The study will focus on patients who have undergone prophylactic colectomy and are under regular endoscopic surveillance. By understanding these factors, the research seeks to identify variations in polyp development among patients with the same genetic mutation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of Familial Adenomatous Polyposis who have undergone prophylactic colectomy and are regularly monitored through endoscopic procedures.
Not a fit: Patients who have recently taken antibiotics or probiotics, or those who are incarcerated, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for monitoring and managing polyp development in FAP patients, potentially reducing the risk of colorectal cancer.
How similar studies have performed: While the role of gut microbiota in colorectal cancer has been explored, this specific prospective evaluation in FAP patients is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years * Non-opposition obtained * Prophylactic colectomy for at least 2 years in the context of APC-related familial adenomatous polyposis with ileorectal or ileoanal anastomosis * Included in the national POLYPOSE database * Regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot or Hôpital de la Croix-Rousse * Having performed at least 2 endoscopies as part of follow-up Exclusion Criteria: * Antibiotic therapy within 2 months prior to stool sampling * Taking probiotics for less than 1 month * Person deprived of liberty by judicial or administrative decision
Where this trial is running
Lyon, France and 1 other locations
- Hôpital Edouard Herriot — Lyon, France, France (Recruiting)
- Hôpital de la Croix Rousse — Lyon, France, France (Recruiting)
Study contacts
- Study coordinator: Nicolas BENECH, MD PhD
- Email: nicolas.benech@chu-lyon.fr
- Phone: +33426109435
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.