NCT04824053Recruiting
Effects of UNICLA-A2 Dairy Products on Patients at High-risk of Colorectal Cancer Development
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 24 Mar 2021
- Start date
- 28 Feb 2022
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Diseases
- Colorectal cancer
- NCT number
- NCT04824053
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 28 Feb 2022 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of allergic reaction attributed to compounds of similar chemical composition to the study agents.
- History of familial adenomatous polyposis.
Other
- Incomplete colonoscopy or with poor quality criteria, Boston \<6.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Angel Lanas Arbeloa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.