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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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 population

Patients with proven familial adenomatous polyposis genetically operated (total colectomy with ileoanal or ileorectal anastomosis), included in the national POLYPOSE database and with regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot, Lyon, France or Hôpital de la Croix-Rousse, Lyon, France

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling of feces and duodenal fluids

    Other intervention

    * Blood sampling (plasmotheque and serotheque): 2 tubes (EDTA (5mL) and dry (5mL)) during hospitalization * Fecal sampling (fecal library): A stool sample (approx. 2g) will be taken 48 hours before the endoscopy at home for outpatient or during hospitalization * Duodenal aspiration fluid (6-10 mL in total): before and after mucosal lavage with sterile isotonic saline on the day of endoscopy. * Food and Lifestyle Questionnaire (FFQ) during inclusion

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with genetically proven familial adenomatous polyposis undergoing surgery1 intervention

Trial outcomes

Primary outcomes

1

Fecal microbiota composition

Analysis of fecal microbiota composition as a function of the cumulative number of reservoir (rectum or ileal) adenomas treated over 3 consecutive endoscopies

Time frame
Within 48 hours of endoscopy

Secondary outcomes

Other outcomes

Sponsors and contacts

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