Investigating factors that influence polyp development in patients with Familial Adenomatous Polyposis
Official title: Microbial and Environmental Factors Associated With Polyps Development in Familial Adenomatous Polyposis
Run by Hospices Civils de Lyon · NCT06614738 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon, France and 1 other locations) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | December 17, 2028 |
| Study ends | May 17, 2029 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT06614738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have recently taken antibiotics or probiotics, or those who are incarcerated, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Classifying duodenal polyps in familial adenomatous polyposis
This project will test two risk models to see if they better predict dangerous duodenal polyps and cancer risk in people with genetically confirmed FAP.
-
Personalized home treadmill exercise for people with Familial Adenomatous Polyposis (FAP)
This trial will try different amounts of home treadmill exercise in people with FAP who have at least five rectal polyps to see if exercise can help prevent polyps from coming back.
-
TPST-1495 treatment for people with familial adenomatous polyposis
This trial will try an oral drug called TPST-1495 to see if it reduces the number of polyps in the small bowel and colon in people with familial adenomatous polyposis.
-
10 cm versus 15 cm J-shaped ileal pouch after IPAA surgery
This trial will see if a 10 cm or a 15 cm J-pouch gives better bowel function and quality of life for people having IPAA for ulcerative colitis or familial adenomatous polyposis.
-
ONC201 (dordaviprone) for safety and prevention of colorectal polyps in high-risk adults.
This trial tests whether different doses of ONC201 (dordaviprone) are safe and can help prevent new colorectal polyps in adults with familial adenomatous polyposis or a history of multiple adenomas.
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Evaluating REC-4881 for treating Familial Adenomatous Polyposis
This study is testing a new drug called REC-4881 to see if it can help people with Familial Adenomatous Polyposis feel better after their surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.