RecruitingNCT06614738

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


Sponsor

Hospices Civils de Lyon

Enrollment

50 participants

Start Date

Dec 17, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how gut bacteria (microbiome) and environmental factors influence the development of polyps in people with familial adenomatous polyposis (FAP) — a genetic condition that causes hundreds of polyps to grow in the bowel, greatly increasing cancer risk. Participants will provide stool, urine, blood, and tissue samples. **You may be eligible if...** - You are 18 years old or older - You have FAP caused by an APC gene mutation - You had a preventive bowel surgery (colectomy) at least 2 years ago - You are registered in the national POLYPOSE database and undergo regular endoscopic monitoring at one of the participating hospitals **You may NOT be eligible if...** - You have not had a colectomy, or it was less than 2 years ago - You are not enrolled in the POLYPOSE national registry - You object to participation after being informed about the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSampling 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


Locations(2)

Hôpital Edouard Herriot

Lyon, France, France

Hôpital de la Croix Rousse

Lyon, France, France

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NCT06614738


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