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NCT06614738Recruiting

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

Microbial and Environmental Factors Associated With Polyps Development in Familial Adenomatous Polyposis

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
24 Sept 2024
Start date
17 Dec 2024
Primary completion date
17 Dec 2028
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT06614738

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 17 Dec 2024 to the primary completion date, 17 Dec 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Antibiotic therapy within 2 months prior to stool sampling

Other

  • Taking probiotics for less than 1 month
  • Person deprived of liberty by judicial or administrative decision

Who the study is looking for

  • ≥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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital de la Croix Rousse
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Hopital Edouard Herriot
Coordinator of this site? Confirm its status
LyonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.