Status:
RECRUITING
Effects of UNICLA-A2 Dairy Products on Patients At High-risk of Colorectal Cancer Development
Lead Sponsor:
Instituto de Investigación Sanitaria Aragón
Collaborating Sponsors:
Cooperativas Lacteas Unidas
Hospital Clínico Universitario Lozano Blesa
Conditions:
Colorectal Polyp
Eligibility:
All Genders
18-80 years
Phase:
NA
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 i...
Detailed Description
Colorectal cancer (CRC) is one of the most frequent cancers in the world and has a significant impact in terms of mortality and health costs. It is estimated that CRC causes around 900,000 deaths annu...
Eligibility Criteria
Inclusion
- 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)
- Regular consumer of milk and dairy products.
- Informed consent form signed.
Exclusion
- History of allergic reaction attributed to compounds of similar chemical composition to the study agents.
- Incomplete colonoscopy or with poor quality criteria, Boston \<6.
- Concomitant acetylsalicylic acid (ASA), NSAIDs, misoprostol, corticosteroids or statins needed on a regular or predictable basis during the time of the study.
- Previous gastrointestinal surgery (colon or small intestine or gastric) that affects the absorption of nutrients.
- History of familial adenomatous polyposis.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04824053
Start Date
February 28 2022
End Date
December 15 2026
Last Update
February 27 2025
Active Locations (1)
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1
Angel Lanas Arbeloa
Zaragoza, Zaragoza, Spain, 50009