Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
NCT ID: NCT07290023
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
126 participants
OBSERVATIONAL
2021-01-11
2024-01-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Aim: The main objective is to compare the composition of the intestinal and oral microbiota of individuals diagnosed with serrated polyposis syndrome with individuals with sporadic serrated polyps, adenomatous polyps and without polyps. Among the secondary objective is to establish the prevalence of Fusobacterium nucleatum in oral and fecal samples.
* Methodology: Observational, case-control and multicenter study. Prospective inclusion for 24 months of all patients diagnosed with serrated polyposis syndrome, associated with three control groups: individuals without polyps, individuals with sporadic serrated lesions and individuals with adenomas. Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Serrated polyposis syndrome
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
No interventions assigned to this group
Individuals with sporadic serrated lesions
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
No interventions assigned to this group
Individuals with adenomas
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
No interventions assigned to this group
Individuals without polyps
Clinical and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2\) Individuals who have a recent colonoscopy (\<3 months) in which it is at least dry a serrated lesion proximal to the rectum ≥ 5 mm. Must not present ≥ 5 serrated lesions metachronous or synchronous. 3) Individuals who have had a recent colonoscopy (\<3 months) with resection of the less one adenoma ≥ 5 mm. 4) Individuals who have had a recent colonoscopy (\<3 months) without polyps.
Exclusion Criteria
* Consumption of antibiotics, probiotics or prebiotics in the last 3 months.
* Incomplete colonoscopy or with inadequate preparation in some section.
* Adenomatous, serrated or indeterminate polyps synchronous in the inclusion colonoscopy except in the group of serrated polyposis syndrome.
* Colorectal cancer or hamartomatous polyps in inclusion colonoscopy.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lara Aguilera Castro
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Research Institute Barcelona, Spain, 08035
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lara Aguilera Castro
Barcelona, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cullin N, Azevedo Antunes C, Straussman R, Stein-Thoeringer CK, Elinav E. Microbiome and cancer. Cancer Cell. 2021 Oct 11;39(10):1317-1341. doi: 10.1016/j.ccell.2021.08.006. Epub 2021 Sep 9.
He X, Wu K, Ogino S, Giovannucci EL, Chan AT, Song M. Association Between Risk Factors for Colorectal Cancer and Risk of Serrated Polyps and Conventional Adenomas. Gastroenterology. 2018 Aug;155(2):355-373.e18. doi: 10.1053/j.gastro.2018.04.019. Epub 2018 Apr 24.
Avelar-Barragan J, DeDecker L, Lu ZN, Coppedge B, Karnes WE, Whiteson KL. Distinct colon mucosa microbiomes associated with tubular adenomas and serrated polyps. NPJ Biofilms Microbiomes. 2022 Aug 29;8(1):69. doi: 10.1038/s41522-022-00328-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR(AG)400/2020
Identifier Type: -
Identifier Source: org_study_id