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Search / Trial NCT06614738

Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis (MicrobEnvironment in FAP)

Launched by HOSPICES CIVILS DE LYON · Sep 24, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Familial Adenomatous Polyposis Microbiota Colorectal Cancer Nutrition

ClinConnect Summary

This clinical trial, called "MicrobEnvironment in FAP," is studying how certain microbes in the gut and environmental factors may influence the development of polyps in people with Familial Adenomatous Polyposis (FAP). FAP is a genetic condition that leads to the formation of many growths, known as adenomas, in the colon and small intestine, which can turn into cancer if not treated. The trial aims to understand why some people with the same genetic mutation develop polyps more quickly than others and whether the gut bacteria play a role in this process.

To be eligible for the trial, participants must be at least 18 years old, have undergone a preventive surgery to remove the colon (called prophylactic colectomy) for at least two years, and be part of a national database for FAP patients. Additionally, they should have had regular endoscopies, which are tests to look inside the digestive tract. Participants can expect to provide stool samples and undergo evaluations to help researchers learn more about the connection between gut microbes and polyp development. It's important to note that individuals on antibiotics or probiotics shortly before the study may not be eligible. This research could provide valuable insights into managing FAP and potentially improving patient care.

Gender

ALL

Eligibility 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

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Lyon, , France

Lyon, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported