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A Clinical Trial in Colorectal Cancer evaluates the impact of Hifas da Terra’s natural immunomodulator Mico-Digest 2.0

    Micromarker clinical trial mico-Digest
    • Hifas da Terra (HdT) and the Fundación Biomédica Galicia Sur have initiated a clinical trial to evaluate the new natural formula Mico-Digest 2.0 in 144 patients with colorectal cancer. This is the first clinical study in Spain carried out with compounds derived from medicinal mushrooms.
    • The aim of the clinical trial in colorectal cancer is to study whether taking this nutraceutical reduces post-operative complications following surgery, which affect 20% of patients.
    • This study, which is currently being carried out at the University Hospital of Ourense, is part of the final phase of the collaborative R&D project Micromarker, co-led by the Galician multinational biotech company Hifas da Terra, and is supported by the CDTI, the Spanish government’s funding mediator for business R&D&I.
    • Hifas da Terra was founded in 1998 by Catalina Fernández de Ana Portela, a biologist, mycologist and doctoral candidate in clinical oncology research at the University of Santiago de Compostela. The company, a pioneering biotechnological project born in Galicia, has become an international leader in the development of natural products for human health based on medicinal mushrooms.

    Hifas da Terra and the Fundación Biomédica Galicia Sur are collaborating on a clinical trial using Mico-Digest 2.0, a natural mushroom formula developed by HdT, which works as a natural immunomodulator. The trial is studying one of HdT’s most innovative products, which contains medicinal mushroom extracts with a high concentration of natural bioactive compounds. The study is registered in the international portal clinicaltrials.gov, and will evaluate the impact of Mico-Digest 2.0 supplementation in relation to the rate of postoperative complications, modification of the microbiota, the reduction of inflammatory parameters and digestive wellbeing; aspects related to the immune response of patients.

    In the summer of 2021, the Pontevedra-Vigo-Ourense Research Ethics Committee, promoted by the Fundación Biomédica Galicia Sur, authorised this clinical trial, which, for the first time, includes a nutraceutical from Hifas da Terra made from a synergistic combination of several medicinal mushroom extracts, with the objective of reducing the risk of postoperative complications in patients with colorectal cancer undergoing surgery.

    Fungal polysaccharides have attracted attention for their role in modulating the gut microbiota. It appears that this type of polysaccharide could reduce pathogen levels and stimulate the growth of beneficial microorganisms. Their anti-inflammatory activity has also been observed. Research has also demonstrated that the combination of a range of different fungal extracts sends multiple stimuli to the immune system by increasing intracellular reactions and interactions. Therefore, the synergistic mushroom extract nutraceutical MICODIGEST 2.0 could be used to reduce complications after colorectal cancer surgery.

    The study titled, “Randomised double-blind clinical trial to evaluate the effect of preoperative administration of the nutraceutical MICODIGEST 2.0 on complications associated with surgery for colorectal cancer treated with curative intent,” is a pioneering trial in the field of oncology. This clinical study will evaluate how the prebiotic and anti-inflammatory effects of Mico-Digest 2.0 from Hifas da Terra can reduce postoperative complications that affect 20% of patients undergoing surgery.

    According to the R&D department of Hifas da Terra, these complications are also a risk factor for the recurrence of the disease in different types of neoplasms. “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 look at the inflammatory impact of modifying the microbiota,” they say. “We hope that the application of the nutraceutical Mico-Digest 2.0, due to its anti-inflammatory and microbiota modulating effects, will have a positive effect on the patient’s immune response,” they add.

    Micromarker clinical trial mico-Digest

    This study is part of the final phase of the collaborative R&D project Micromarker, which started in 2018, and is assessing the relationship between gut microbiota modulation and colorectal cancer progression in proprietary studies through various pre-trial phases in patients

    The results of these initial phases allowed the formulation of the extracts with the best prebiotic and anti-inflammatory activity demonstrated in vitro. The conclusions have led to the development of a new formula that will be evaluated in the trial with patients whose production process will be protected under patent, following a favourable report from the Spanish Patent and Trademark Office.

    Hifas da Terra explains that, although certain genetic factors contribute to the onset of colorectal cancer, the microbiota or intestinal flora seems to play an important role in its development and progression and in the quality of life of these patients. Dysbiosis or imbalance of microorganisms present in the normal microbiota is a common feature in patients with colon and rectal cancer, and inflammation are two of the most important mechanisms related to the disease.

    The microbiota or intestinal flora is the group of microorganisms that live in the intestine of human beings on a regular basis, maintaining a symbiotic relationship. Most are bacteria that maintain a delicate balance with other microorganisms and are beneficial to the body, as they are involved in numerous physiological processes such as the metabolism of certain carbohydrates, the activation of the immune system, the regulation of intestinal cell growth and the synthesis of certain vitamins, such as B and K vitamins.

    Poor gut microbiota can contribute to the development of cancer and various metabolic disorders that lead to inflammation in the gut, liver and brain. Studies show that taking medicinal mushrooms influences the microbiota, but controlled clinical trials in patients like this one are needed to fully understand the multiple benefits of medicinal mushrooms in cancer and human health. 

    This clinical trial will provide analytical data on inflammatory markers and other data related to digestive wellbeing, before and after supplementation with Mico-Digest 2.0.  “We have already studied the effect of mushrooms on the immune system, but this new study will allow us to assess their ability to modify the intestinal microbiota and how mushroom extracts act positively against certain markers such as inflammation,” says Catalina Fernández de Ana, Founder and President of Hifas da Terra.

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