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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: alanas@unizar.es
• Phone: 0034 976 76 57 86

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting recurrence of high-risk colorectal polyps using microbiota and metabolites

  This study is trying to see if the bacteria and substances in the gut can help predict if high-risk colorectal polyps will come back after they've been removed.

  Recruiting Peking Union Medical College Hospital · Beijing · NCT06957626

• Using AI to improve the diagnosis of small colorectal polyps

  This study is testing whether using AI during colonoscopy can help doctors find small colorectal polyps more accurately, which could reduce unnecessary procedures for patients.

  Recruiting The First Hospital of Jilin University · Changchun, Jilin · NCT06791408

• Evaluating a computer-aided system for measuring colorectal polyp sizes

  This study is testing a new computer program to see if it can measure the size of colorectal polyps more accurately during colonoscopy compared to traditional methods.

  Recruiting Changhai Hospital · Shanghai, Shanghai Municipality · NCT06715384

• Non-invasive urine and stool tests for early colorectal cancer diagnosis

  This study is testing if special urine and stool tests can help find colorectal cancer early in patients who have already had a positive blood test.

  Recruiting at 2 sites Institut Investigacio Sanitaria Pere Virgili · Reus, Tarragona and 1 other locations · NCT06452745

• Blood test for early detection of colorectal cancer and adenomas

  This study is testing a new blood test to see if it can help find early signs of colorectal cancer and adenomas in people who are already scheduled for a colonoscopy.

  Recruiting at 6 sites City of Hope Medical Center · Monrovia, California and 5 other locations · NCT06342440

• Training endoscopists to recognize and interpret resection scars after polyp removal

  This study tests whether an online training tool helps endoscopists of any experience better detect recurrent or residual adenoma at endoscopic resection scars using images from colonoscopy.

  Recruiting University Hospital, Ghent · Ghent · NCT06193356

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.