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

Recruiting

• Conditions: Familial Adenomatous Polyposis
• Interventions: Other: Sampling of feces and duodenal fluids

• Registration Number: NCT06614738
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2024-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-03-17
• Study Completion: 2027-05-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with genetically proven familial adenomatous polyposis undergoing surgery	Sampling of feces and duodenal fluids	Patients with familial adenomatous polyposis hospitalized for regular endoscopic follow-up by upper and lower digestive endoscopy at Hôpital Edouard Herriot, Lyon, France or Hôpital de la Croix-Rousse, Lyon, France

Primary Outcome Measures

Name	Time	Method
Fecal microbiota composition	Within 48 hours of endoscopy	Analysis of fecal microbiota composition as a function of the cumulative number of reservoir (rectum or ileal) adenomas treated over 3 consecutive endoscopies

Trial Locations

Locations (2)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France