Kolorektal Kanser (colorectal cancer) Gelişme Riski Yüksek Hastalarda UNICLA-A2 Süt Ürünlerinin Etkileri

Sade dilde özet

Bu çalışma, kolorektal kanser (colorectal cancer) gelişme riski yüksek olan hastalarda, genetik olarak seçilmiş A2 beta-kazein inek sütünden yapılan UNICLA-A2 süt ürünlerinin etkilerini geleneksel süt ürünleriyle karşılaştırarak incelemektedir. Çalışmaya, kolorektal kanser tarama programında yüksek riskli polip saptanmış ve düzenli süt ürünü tüketen kişiler katılabilmektedir. Faz uygulanmayan bir çalışma olarak yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Katılımcı alıyor

Sponsor

Instituto de Investigación Sanitaria Aragón

Müdahale

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

Başlangıç

28.02.2022

Tahmini bitiş

15.12.2028

Ülkeler

Spain

İlgili genler

Merkezler

• Zaragoza, Spain

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.