NCT06614738 Microbial and Environmental Factors Associated With Polyps Development in Familial Adenomatous Polyposis (MicrobEnvironment in FAP)
| NCT ID | NCT06614738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Familial Adenomatous Polyposis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2028-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-17 with a primary completion date of 2028-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06614738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Familial Adenomatous Polyposis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06614738 currently recruiting?
Yes, NCT06614738 is actively recruiting participants. Contact the research team at nicolas.benech@chu-lyon.fr for enrollment information.
Where is the NCT06614738 trial being conducted?
This trial is being conducted at Lyon, France, Lyon, France.
Who is sponsoring the NCT06614738 clinical trial?
NCT06614738 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 100 participants.