Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Inflammation

Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Herbal and Botanical

Selenium

Caseins

Antioxidants

Protective Agents

Trace Elements

Chelating Agents

Flax

Participants (n=17) ingest milk and dairy products made from cows homozygous for beta casein A2 during 3 months. These products are also enriched in insaturated fatty acids and selenium. The daily intake reflects the habitual consumption habits. Recommended amounts are 250 mL of milk, a yogurt and 50 g fresh cheese per day.

Participants (n=17) ingest conventional dairy products and milk daily during 3 months. As happens in the UNICLA-A2 arm, the daily intake reflects habitual dairy consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, recommended amounts are 250 mL of milk, a yogurt and 50 g fresh cheese per day.

The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 250 mL of milk. The intervention duration will be 3 months

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

The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of one yogurt. The intervention duration will be 3 months

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

The daily intake should reflect habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 50 g of fresh cheese. The intervention duration will be 3 months

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

Angel Lanas Arbeloa, MD, PhD

Pilar Irun, PhD

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

Colorectal cancer (CRC) is one of the most frequent cancers in the world and has a significant impact in terms of mortality and health costs. It is estimated that CRC causes around 900,000 deaths annually, mainly due to diagnoses made in advanced stages. Colorectal adenomas (CRA) are precancerous lesions that develop into colorectal cancer following a well-known process into the adenoma-carcinoma sequence. Prevention programs include screening for CRA and removing precancerous lesions by polypectomy, but the high recurrence rates after polypectomy makes it necessary to research on potential chemopreventive agents that may reduce this risk. Dietary recommendations or chemoprevention with different nutritional substances (diets rich in fiber, or poor in red meat, etc) or pharmacological substances including vitamin D, calcium, fatty acids, salicylic acetyl acid, nonsteroidal anti-inflammatory agents (NSAIDs), etc) have been studied. In this way, it seems reasonable to evaluate the effect caused by the administration of certain nutrients that affect lipid and protein metabolism involved in cellular homeostasis, in the preservation of the colonic mucosa or the development of lesions may have in populations at risk.

UNICLA A2 dairy products have a different nutrient profile than conventional ones. UNICLA A2 products have higher content in unsaturated fats, that is to say, increased content of healthy fatty acids such as oleic, linolenic, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and conjugated linoleic acid (CLA). Previous studies have suggested a contribution of ω-3 polyunsaturated fatty acids (PUFAs) to reduce pro-inflammatory markers and, have shown they have antimicrobial and negative properties in relation to biofilm formation. These types of biofilm structures are characteristic of proximal CRC. For these reason, ω-3 PUFAs it is thought that they could modify the altered intestinal microbiota in patients at high risk of CRC towards a less pathogenic environment, correcting the gut dysbiosis. Moreover, they have higher selenium levels (Se), an element with essential biological functions which has been suggested improving effects in combination with other anticancer agents in CRC and taking part in the modulation of several processes, such as the immune response, apoptotic cell death, DNA repair, response to oxidative stress, carcinogenic metabolism, tumorigenesis and angiogenesis. Finally, they contain type A2 beta casein, which differs from A1 beta casein by a single amino acid at position 67 of a 107 amino acid chain. This fact is very important because beta casein contains a chain of amino acids called "beta casomorphin" (BCM7) with negative health effects reported. The proline 67 in beta casein A2 has a strong bond with BCM7 that does not allow it to separate and flow freely in milk to be absorbed. However, the mild bond due to histidine 67 in beta casein A1 allows BCM7 to reach the intestinal wall and be absorbed, being associated with intestinal discomfort, gastrointestinal transit time and stool consistency disturbances, abdominal pain and, increased levels of some inflammatory markers.

For these reasons, in this proposal the investigators aim to determine whether the change from conventional dairy products to UNICLA-A2 products but maintaining the habitual consumption habits in "real life" conditions, without forcing or inducing greater consumption, will have positive effects on maintaining the intestinal integrity by reducing the inflammatory profile, and leading the gut microbiota to a less pathogenic environment in patients at high-risk of CRC development.

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

The C-reactive protein and calprotectin are measured by conventional methods in the University Clinic Hospital Lozano Blesa and the circulating biomarkers IL-6, MIC-1 and TNFα by enzyme-linked immunosorbent assay

Stool samples are collected for DNA extraction and ulterior metagenomic analysis of the fecal microbiota's composition. Library construction is carried out with the Ion 16S™ Metagenomics Kit which permits PCR amplification of hypervariable regions of the 16S rDNA gene from bacteria and the material obtained is subjected to next-generation sequencing (NGS) to see the proportions of the main groups of microorganisms in the sample.

The number of participants in each arm who develop one or more colorectal adenomas is determined in the follow-up colonoscopy (adenoma detection rate), as well as the presence of advanced or not advanced adenomas, serrated polyps, subtype, location and the total number of adenomas per participant.

FEIRACO LACTEOS SL

Hospital Clínico Universitario Lozano Blesa

Instituto de Investigación Sanitaria Aragón

Head of Digestive Service (University Clinic Hospital Lozano Blesa) and Principal Investigator

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Hypothyroidism

Endocrine System Diseases

Anti-Infective Agents

Other Dietary Supplements

Iodine

Cadexomer iodine

Acidophilus

Bifidobacterium

Taking probiotics containing Bifidobacterium infantis, Lactobacillus acidophilus and Enterococcus faecalis for 30 days

Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment

Probiotic

Yunwei Wei

Thyroid cancer is a common neck malignancy. Currently, total thyroidectomy or subtotal thyroidectomy is the main method for the treatment of thyroid cancer patients. However, some thyroid cancer may still have residual thyroid tissue after operation. Therefore, in the differentiated thyroid In the treatment of cancer, iodine 131 treatment is mainly used because iodine 131 can emit high-energy beta rays, destroying the residual tissue of thyroid cancer and achieving good therapeutic goals. However, in the treatment of iodine-131, certain salivary glands are inevitably damaged, and the patient will have dry mouth symptoms. After the same treatment with iodine-131, some patients will experience gastrointestinal reactions such as nausea and vomiting. The therapeutic efficacy of iodine-131 depends on the lesion's uptake of iodine-131, which requires an increase in serum TSH levels. All patients in this study had stopped taking thyroid hormone for 3-4 weeks before iodine 131 treatment, making serum The TSH level is greater than 30 mU/L. At this time, the patient is in hypothyroidism. People with hypothyroidism experience dry mouth, dry skin, constipation, pain, cold, poor memory, depression, and weight gain. Many studies have pointed out that some cancer treatments, such as chemotherapy and radiotherapy, also have an impact on the microbial flora. However, studies on the relationship between microecology, hypothyroidism and iodine-131 treatment, probiotics in the prevention of hypothyroidism and iodine-131 treatment The link between the effects of side effects remains unclear. Therefore, the team will conduct a correlation study between microbes and hypothyroidism, iodine-131 treatment.

Thyroid cancer is a common neck malignancy and it mainly affects thyroid follicular cells or parafollicular cells. Thyroid cancer in various tumors in the body, the ratio can reach 1.2% to 2.3%. Thyroid cancer can be divided into differentiated thyroid cancer, squamous cell carcinoma, undifferentiated carcinoma, and medullary carcinoma, among which the incidence of differentiated thyroid carcinoma is more than 90%. At present, total thyroidectomy or subtotal thyroidectomy is the main method for the treatment of thyroid cancer patients, but some thyroid cancer may still have residual thyroid tissue after operation. Therefore, in the treatment of differentiated thyroid cancer, iodine 131 is mainly used. Treatment, because iodine 131 can emit high-energy beta rays, destroying the residual tissue of thyroid cancer, to achieve good therapeutic purposes. However, due to the presence of sodium iodine symporter in salivary glands and thyroid, it is inevitable that certain salivary glands will be damaged in the treatment of iodine 131, and patients will have dry mouth symptoms. Some patients with nausea 131 will also experience nausea and vomiting. Gastrointestinal reaction. Iodine 131 treatment is divided into two steps: 1 removal of residual thyroid tissue; 2 removal of cancer lesions and metastases. The curative effect of 131I depends on the lesion's uptake of iodine-131, which requires an increase in serum TSH levels. All patients in this study had stopped taking thyroid hormone for 3 to 4 weeks before iodine-131 treatment. The TSH level is greater than 30 mU/L. At this time, the patient is in hypothyroidism. People with hypothyroidism experience dry mouth, dry skin, constipation, pain, cold, poor memory, depression, and weight gain. Many studies have pointed out that some cancer treatments, such as chemotherapy and radiotherapy, also have an impact on the microbial flora. However, studies on the relationship between microecology, hypothyroidism and iodine-131 treatment, probiotics in the prevention of hypothyroidism and iodine-131 treatment The link between the effects of side effects remains unclear. Therefore, the team will conduct a correlation study between microbes and hypothyroidism, iodine-131 treatment.

the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

Distinct Shifts in the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism

Improved side-effects in patients, such as reduced diarrhea and improved dry mouth symptoms

First Affiliated Hospital of Harbin Medical University

Rare Diseases

Neuroendocrine Tumors

Endocrine Gland Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

Antineoplastic Agents

Pancrelipase

Pancreatin

Lanreotide

naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment

Historical control group (retrospective data) Patients, with normal endoscopic and body imaging results, having had fecal ARN16s sequencing who were assigned as control subjects for microbiota analyses.

Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing

Biological sampling

IRADJ SOBHANI, MD-PHD

Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.

fecal sample blood sample

blood sample is part of routine medical care and fecal sample is a non invasive collection of elements from human body, allowing the study to be categorised as a non-interventional research (approved by ethics commitee)

Please see:

"Arrêté du 12 avril 2018 fixant la liste des recherches mentionnées au 3° de l'article L. 1121-1 du code de la santé publique" , justifying observational study type

Microbiotic Analysis in Digestive Endocrine Tumors

Data are own by Assistance Publique - Hopitaux de Paris, please contact sponsor for further information

bacterial genomic signature by fecal ARN16S analysis at enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of UNICLA-A2 Dairy Products on Patients at High-risk of Colorectal Cancer Development	NCT04824053	Colorectal Poly...	Milk from genet... Conventional mi... Yogurt made fro... Conventional yo... Fresh cheese ma... Conventional fr...	18 Years - 75 Years	Instituto de Investigación Sanitaria Aragón
the Microbiota Are Associated With Iodine-131 Therapy and Hypothyroidism	NCT03574051	Microbiota	Probiotic	18 Years - 65 Years	First Affiliated Hospital of Harbin Medical University
Microbiotic Analysis in Digestive Endocrine Tumors	NCT04198402	Digestive Neuro... Fecal Microbiot... Bacterial Signa...	Biological samp...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for fecal microbiota