NCT04824053 Effects of UNICLA-A2 Dairy Products on Patients At High-risk of Colorectal Cancer Development
| NCT ID | NCT04824053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria Aragón |
| Condition | Colorectal Polyp |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2022-02-28 |
| Primary Completion | 2025-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Dietary intervention with UNICLA-A2 milk products containing beta casein A2 protein, and higher levels of omega-3 fatty acids and selenium may contribute to maintain the intestinal integrity, reduce inflammatory processes, normalize the immune system, protect against oxidative damage and equilibrate the gut microbiota in high-risk colorectal cancer patients who have undergone polypectomy
Eligibility Criteria
Inclusion Criteria: 1. Participants diagnosed with high-risk polyps in the colorectal cancer screening programme or in the relative's colon cancer prevention program or patients who are in follow-up due to prior detection of polyps with any of the following characteristics: * At least 10 adenomas * At least 5 proximal serrated polyps (PSP) * At least 2 serrated polyps with diameters ≥10 mm * Serrated Polyposis Syndrome (SPS) * Early invasive CRC (stage pT1) endoscopically resected (surgery not required) * A sessile or flat lesion ≥ 20 mm with fragmented resection * Patients with previous resection of polyps in which the resection margin was not assessable and are considered susceptible to repeat colonoscopy * Patients with intramucosal carcinoma in situ or invasion of the lamina propria (pTis) 2. Regular consumer of milk and dairy products. 3. Informed consent form signed. Exclusion Criteria: 1. History of allergic reaction attributed to compounds of similar chemical composition to the