Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Locations2 sites (Lyon, France and 1 other locations)
StatusRecruiting
StartedDecember 17, 2024
Main results expectedDecember 17, 2028
Study endsMay 17, 2029
Registry record updatedMay 27, 2026
Trial IDNCT06614738 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    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.

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  • ONC201 (dordaviprone) for safety and prevention of colorectal polyps in high-risk adults.

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  • Evaluating REC-4881 for treating Familial Adenomatous Polyposis

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.