- The essay includes a Formula prepared by Hifas da Terra with natural bioactive compounds obtained from certain medicinal fungi
- The formula will be will evaluate in relation to the rate of postoperative complications, as well as the Microbiota modification, the reduction of inflammatory parameters and the digestive well -being, aspects related to the immune response of patients
- A total of 144 patients They will participate in this Double blind random clinical trial that will be launched in the Ourense University Hospital in the coming months
- Participation will be offered with patients with Colorectal cancer candidates for surgery with healing intention
- This study is part of the final phase of the Micromarker I+D Collaborative Project, co-driver by the Biotech Hifas da Terra and has the support of the CDTI, the financing mediator of the General Administration of the State of the R&D state
He Ethics Committee of Pontevedra-Vigo-Ourense Research has just authorized a CLINICAL TEST NCT04821258 promoted by the Galicia Sur Biomedical Foundation in which, for the first time, a Hifas Nutraceutic Da Terra elaborated from certain extracts of medicinal fungi whose objective will be the reduction of postoperative complications.
The study whose full title is Double blind randomized closing essay to evaluate the effect of the administration of the nutraceutical Micodigest 2.0 prior to the intervention in the complications associated with the surgery of colorectal cancer treated with healing intention It is a pioneer essay in the oncological field in which It will evaluate how the prebiotic and anti -inflammatory effects of the nutraceutical developed by Hifas da Terra can reduce postoperative complications that affect 20% of patientss that are subject to surgical intervention.
Reduction of complications
As explained by the Hifas Da Terra department, these complications also constitute a risk factor for the recurrence of the disease in different types of neoplasms. They also add, «We know that the bacteria present in the microbiota could play an important role in the prevention of colorectal cancer. In this study we will observe the inflammatory repercussions resulting from the modification of the microbiota ».
The application of Micodigest 2.0 nutraceutical, due to their Microbiota anti -inflammatory and modulator effects, "we hope it acts positively in the patient's immune response".
Pioneer essay in colorectal cancer
He Micromarker I+D Collaborative Project, initiated in 2018, has evaluated through different phases prior to the test in patients, the relationship between the intestinal microbiota modulation and colorectal cancer progression in own studies carried out In vitro and in animal models with the participation of ANFACO-CECOPESCA.
The results of these initial phases allowed the formulation of the extracts with better prebiotic and anti -inflammatory activity demonstrated In vitro. The conclusions have given rise to the development of the formula that the patients of the trial whose production process will be protected under patent, after a favorable report of the Spanish office of patents and brands.
Medicinal fungi as microbiota modulators in cancer
Although certain genetic factors contribute to the appearance of colorectal cancer, the microbiota or intestinal flora seems to have an important role in their development and progression and in the quality of life of these patients. The Disbiosis or imbalance of microorganisms present in the normal microbiota is a common feature in patients with colon cancer And straight, and inflammation are two of the most important mechanisms in relation to the disease.
The microbiota or intestinal flora It is the set of microorganisms that live, regularly, in the intestine of human beings, maintaining a symbiotic relationship. Most are bacteria that maintain a delicate balance with the rest of microorganisms and are beneficial for the body, since they participate in numerous physiological processes such as the metabolism of some carbohydrates, the activation of the immune system, the regulation of the growth of intestinal cells and the synthesis of certain vitamins, such as B and K.
A Poor intestinal microbiota can contribute to cancer development and of various metabolic disorders that lead to inflammation in the intestine, the liver and the brain. The studies show that the taking of medicinal fungi influence the microbiota but controlled clinical trials are required in patients who help to fully understand their multiple benefits in cancer and in human health.
Nutrigen 4.0 project researchers. From left to right: Hugo Barreiro (Anfaco-Cecopesca), Elena Balboa (HDT), Celina Costas (Anfaco-Cecopesca) and Arturo Rodríguez (HDT).
Micromarker clinical trial: safety and efficacy
Through the clinical trial, analytical data related to inflammatory markers and other clinical data related to digestive well -being, before and after the intakes, will be obtained. »We have already studied the effect of fungi on the immune system, but this new study will allow its capacity to modify the intestinal microbiota and how fungal extracts act positively against certain markers such as, for example, inflammation,” adds Catalina Fernández de Ana, general director of the Biotech.
Hifas da Terra investigates the role of fungi in cancer and neurodegenerative, cardiovascular and autoimmune pathologies.