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

Plain-language summary

This study examines the effects of UNICLA-A2 dairy products, made from milk of genetically selected A2 beta-casein cows, compared with conventional dairy products, in patients at high risk of developing colorectal cancer. It is open to people who were found to have high-risk polyps in colorectal cancer screening and who regularly consume dairy products. It is a non-phased study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Instituto de Investigación Sanitaria Aragón

Intervention

Milk from genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium, Conventional milk, Yogurt made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium, Conventional yogurt, Fresh cheese made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium, Conventional fresh cheese

Start date

2/28/2022

Estimated completion

12/15/2028

Countries

Spain

Related genes

Locations

• Zaragoza, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.