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 | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2022-02-28 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 study agents. 2. Incomplete colonoscopy or with poor quality criteria, Boston \<6. 3. Concomitant acetylsalicylic acid (ASA), NSAIDs, misoprostol, corticosteroids or statins needed on a regular or predictable basis during the time of the study. 4. Previous gastrointestinal surgery (colon or small intestine or gastric) that affects the absorption of nutrients. 5. History of familial adenomatous polyposis.
Contact & Investigator
Angel Lanas Arbeloa, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas.
Frequently Asked Questions
Who can join the NCT04824053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04824053 currently recruiting?
Yes, NCT04824053 is actively recruiting participants. Contact the research team at alanas@unizar.es for enrollment information.
Where is the NCT04824053 trial being conducted?
This trial is being conducted at Zaragoza, Spain.
Who is sponsoring the NCT04824053 clinical trial?
NCT04824053 is sponsored by Instituto de Investigación Sanitaria Aragón. The principal investigator is Angel Lanas Arbeloa, MD, PhD at University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas.. The trial plans to enroll 34 participants.