Hifas da Terra (HdT) and the Galicia Sur Biomedical Foundation have promoted a study in colorectal cancer to evaluate a new natural formula in 144 participants. This is the first study in Spain carried out with compounds derived from mushrooms.
- The aim of the study is help reduce post-operative complications associated with surgery, which affect 20% of participants.
- This study, currently being carried out at the University Hospital of Ourense, forms part of the final phase of the collaborative R&D project Micromarker, co-led by the Galicia-born multinational biotech Hifas da Terra, with the support of CDTI, the funding intermediary of Spain’s General State Administration for business R&D&I.
- Hifas da Terra was founded in 1998 by Catalina Fernández de Ana Portela, biologist, mycologist and doctoral researcher in clinical oncology at the University of Santiago de Compostela. The company, a pioneering biotechnology project born in Galicia, has become an international leader in the development of mushroom-based supplements for human wellbeing.
Hifas da Terra, in collaboration with the Galicia Sur Biomedical Foundation, has promoted a study with a new formula, the natural formula developed by the Galician company, which is being studied within this research for its role in supporting immune modulation. Specifically, the study includes one of Hifas da Terra’s most innovative products, as it contains a high concentration of natural bioactive compounds obtained from Functional Mushroom extracts. This study, registered on the international portal clinicaltrials.gov, will evaluate the impact of the formula supplementation in relation to the rate of post-operative complications, as well as microbiota modulation, inflammatory marker balance and digestive wellbeing, all of which are aspects connected to adults’ immune response.
The Pontevedra-Vigo-Ourense Research Ethics Committee authorised this study in the summer. Promoted by the Galicia Sur Biomedical Foundation, it is the first study to include a Hifas da Terra nutraceutical made from a synergistic combination of several Functional Mushroom extracts, with the aim of evaluating its role in supporting the reduction of post-operative complication risk in participants with colorectal cancer undergoing surgery.
Fungal polysaccharides have attracted attention for their role in modulating the gut microbiota. This type of polysaccharide may help reduce levels of undesirable microorganisms and support the growth of beneficial microorganisms. Their role in supporting a balanced inflammatory response has also been described. The combination of different fungal extracts may send multiple stimuli to the immune system, increasing intracellular reactions and interactions. Therefore, the fungal extract nutraceutical is being studied for its potential to support participants following colorectal cancer surgery.
The full title of the study is Double-blind randomised study to evaluate the effect of administering the nutraceutical MICODIGEST 2.0 prior to intervention on complications associated with colorectal cancer surgery treated with curative intent. This clinical study will evaluate how the prebiotic effect and inflammatory-response modulation associated with Hifas da Terra’s product may support the reduction of post-operative complications, which affect 20% of participants undergoing surgery.
According to Hifas da Terra’s R&D department, these complications may also constitute a risk factor for disease recurrence in different types of neoplasms. “We know that the bacteria present in the microbiota may play an important role in colorectal cancer prevention. In this study, we will observe the inflammatory-level impact resulting from microbiota modulation,” they explain. “We hope that the application of the nutraceutical, due to its role in inflammatory-response modulation and microbiota balance, will positively support the immune response,” they add.
This study forms part of the final phase of the collaborative R&D project Micromarker, which began in 2018 and has evaluated, through different phases prior to the participant study, the relationship between gut microbiota modulation and colorectal cancer progression in proprietary studies.
The results of these initial phases made it possible to formulate the extracts with the best prebiotic activity and inflammatory-response modulation demonstrated in vitro. The conclusions have led to the development of the new formula that will be evaluated in the participants, and 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 gut flora, appears to play an important role in its development and progression, as well as in participants’ quality of life. Dysbiosis, or an imbalance of microorganisms present in the normal microbiota, is a common feature in participants with colon and rectal cancer, and inflammation is one of the most important mechanisms connected to the disease.
The microbiota, or gut flora, is the set of microorganisms that normally live in the human intestine, maintaining a symbiotic relationship. Most are bacteria that maintain a delicate balance with other microorganisms and are beneficial to the body, as they participate in numerous physiological processes, such as the metabolism of certain carbohydrates, immune system activation, regulation of intestinal cell growth and the synthesis of certain vitamins, such as B vitamins and vitamin K.
A compromised gut microbiota may contribute to the development of cancer and various metabolic disorders that lead to inflammatory processes in the intestine, liver and brain. Studies show that the intake of Functional Mushrooms influences the microbiota, although controlled study in participants, such as this one, are required to fully understand their multiple potential benefits in cancer research and human wellbeing.
Through this study, analytical data will be obtained relating to inflammatory markers and other data connected 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 capacity to modulate the gut microbiota and how mushroom extracts act positively in relation to certain markers, such as inflammatory markers,” says Catalina Fernández de Ana, founder and president of the biotech company.
Hifas da Terra, research as a pillar of the company
Research and innovation form part of Hifas da Terra’s approach to product development and quality.
HdT team works with external research organisations to expand scientific knowledge relating to mushroom-derived ingredients, food supplement formulation, manufacturing processes and quality control.
These activities support the technical development and evaluation of our products. Research projects may examine ingredient characteristics, formulation methods and analytical procedures under controlled conditions.
Research is an ongoing process. Participation in a research project does not, by itself, demonstrate that a commercially available food supplement provides a particular health benefit.
Information about individual food supplements, including their ingredients, recommended daily intake and directions for use, is available on the relevant product pages.