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

NCT06614738 | Recruiting

• 2 other identifiers: 69HCL24_01392024-A01814-43
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Familial Adenomatous Polyposis

Keywords

Familial adenomatous polyposis; microbiota; colorectal cancer; nutrition

Outcome Measures

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

  Within 48 hours of endoscopy

Study Arms (1)

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

Other: Sampling of feces and duodenal fluids

Interventions

Sampling of feces and duodenal fluids 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

Patients with genetically proven familial adenomatous polyposis undergoing surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Edouard Herriot

Lyon, France, 69003, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, France, 69004, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 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 * 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

MeSH Terms

Conditions

Adenomatous Polyposis Coli; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rectal Diseases

Central Study Contacts

Nicolas BENECH, MD PhD

CONTACT

+33426109435; nicolas.benech@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

FR (2)