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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Familial Adenomatous Polyposis

Treatments: Other: Sampling of feces and duodenal fluids

Study type: Observational

Funder types: Other

Identifiers

NCT06614738

69HCL24_0139

2024-A01814-43 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients with genetically proven familial adenomatous polyposis undergoing surgery

Description:

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

Treatment:

Other: Sampling of feces and duodenal fluids