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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-17

Study Completion Date

2027-05-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Familial Adenomatous Polyposis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with genetically proven familial adenomatous polyposis undergoing surgery

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

Sampling of feces and duodenal fluids

Intervention Type OTHER

* 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

Interventions

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Sampling of feces and duodenal fluids

* 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No