NCT07290023Completed
Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
Characterization of the Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
* 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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 126 (actual)
- First submitted
- 4 Dec 2025
- Start date
- 11 Jan 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT07290023
What you commit to
- Study type: Observational
- Participants enrolled: 126
- From 11 Jan 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Suspicion of hereditary syndromes of predisposition to CRC (\> 20 metachronous adenomas, Familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, Cowden, juvenile polyposis).
- 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.
Other
- Consumption of antibiotics, probiotics or prebiotics in the last 3 months.
- Incomplete colonoscopy or with inadequate preparation in some section.
Who the study is looking for
- \- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lara Aguilera Castro Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.