Actively Recruiting

Age: 18Years +
All Genders
NCT06614738

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

Led by Hospices Civils de Lyon · Updated on 2025-01-30

50

Participants Needed

2

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder linked to a mutation in the APC gene, associated with the development of multiple colonic and duodenal adenomas, which in 100% of cases progress to colorectal cancer (CRC) if left untreated. Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation, followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir. However, there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations. This strongly suggests the additional role of environmental factors. Recently, the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP, but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied, particularly at duodenal level in operated patient.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Non-opposition to study participation obtained
  • Had prophylactic colectomy for at least 2 years due to APC-related familial adenomatous polyposis with ileorectal or ileoanal anastomosis
  • Registered in the national POLYPOSE database
  • Undergoing regular upper and lower gastrointestinal endoscopic follow-up at Hôpital Edouard Herriot or Hôpital de la Croix-Rousse
  • Completed at least 2 endoscopies as part of follow-up
Not Eligible

You will not qualify if you...

  • Received antibiotic therapy within 2 months before stool sampling
  • Using probiotics for less than 1 month
  • Person deprived of liberty by judicial or administrative decision

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hôpital Edouard Herriot

Lyon, France, France, 69003

Actively Recruiting

2

Hôpital de la Croix Rousse

Lyon, France, France, 69004

Actively Recruiting

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Research Team

N

Nicolas BENECH, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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