Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
December 4, 2025 updated by: Hospital Universitari Vall d'Hebron Research Institute
Characterization of the Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
- Background: Serrated polyposis syndrome is the most common colorectal polyposis syndrome. Its pathogenesis is still unknown and its diagnosis is based on clinical criteria. Despite advances in its knowledge, the intestinal microbiota of these patients has not been characterized, nor has the role of Fusobacterium nucleatum in their lesions been evaluated.
- 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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona
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Barcelona, Barcelona, Spain, 08035
- Lara Aguilera Castro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Gastroenterology consultations patients.
Description
Inclusion Criteria:
- Individuals who meet the diagnostic criteria for serrated polyposis syndrome and who have a recent colonoscopy (<3 months) in which at least one serrated lesion is resected (defined as hyperplastic polyp or sessile serrated lesion / polyp) proximal to the rectum ≥ 5 mm.
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:
- Suspicion of hereditary syndromes of predisposition to CRC (> 20 metachronous adenomas, Familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, Cowden, juvenile polyposis).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Serrated polyposis syndrome
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
|
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Individuals with sporadic serrated lesions
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
|
|
Individuals with adenomas
Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
|
|
Individuals without polyps
Clinical and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of Intestinal Microbiota through 16S Sequencing
Time Frame: 1 year
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Characterization of Intestinal Microbiota through 16S Sequencing
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1 year
|
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Characterization of Oral Microbiota through 16S Sequencing
Time Frame: 1 year
|
Characterization of Oral Microbiota through 16S Sequencing
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum.
Time Frame: 1 year
|
Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum in saliva and feces.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lara Aguilera Castro, Vall d'Hebron Research Institute Barcelona, Spain, 08035
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 2, 2024
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)400/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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