Effects of UNICLA-A2 Dairy Products on High-risk Colorectal Cancer Patients

Comparative Analysis of the Effects of UNICLA-A2 Against Conventional Dairy Products Administered Daily in Patients at High-risk Colorectal Cancer Development Who Have Undergone Polypectomy

This study is testing whether eating UNICLA-A2 dairy products can help people at high risk for colorectal cancer feel better and improve their gut health after having polyps removed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria Aragón (Academic / other)
• Locations: 1 site (Zaragoza, Zaragoza)
• Trial ID: NCT04824053 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of UNICLA-A2 dairy products, which contain beta casein A2 protein and higher levels of omega-3 fatty acids and selenium, on patients at high risk for colorectal cancer. The intervention aims to maintain intestinal integrity, reduce inflammation, normalize the immune system, protect against oxidative damage, and balance gut microbiota in individuals who have undergone polypectomy. Participants will consume UNICLA-A2 milk, yogurt, and fresh cheese, and their health outcomes will be monitored to assess the effectiveness of these dietary changes.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with high-risk polyps or those in follow-up after polypectomy.

Not a fit: Patients with a history of allergic reactions to similar dairy products may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of colorectal cancer recurrence in high-risk patients.

How similar studies have performed: While dietary interventions have been explored in cancer prevention, the specific use of UNICLA-A2 dairy products represents a novel approach that has not been extensively tested.

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.

Where this trial is running

Zaragoza, Zaragoza

• Angel Lanas Arbeloa — Zaragoza, Zaragoza, Spain (Recruiting)

Study contacts

• Principal investigator: Angel Lanas Arbeloa, MD, PhD — University Hospital Lozano Blesa. IIS Aragón. CIBER de Enfermedades Hepáticas y Digestivas.
• Study coordinator: Angel Lanas Arbeloa, MD, PhD

Conditions Colorectal Polyp; polyp; inflammation; fecal microbiota