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A routine review, a question that seems out of place, more tests than planned and a devastating diagnosis: 'You have non-alcoholic steatohepatitis'. And what is that? A severe form of fatty liver. A disease as dangerous as it seems. And when it is detected, it is usually in very advanced stages where the only way out can be liver transplantation.
Fatty liver is the most frequent liver pathology in the world. Not surprisingly, it affects 30% of the general population and up to 70-90% of people with obesity and type 2 diabetes. Therefore, finding a drug that sheds light at the end of the tunnel is crucial.
A team of researchers from the University Assistance Complex of Leon and the Institute of Biomedicine (Ibiomed) of the University of Leon studies the alteration of the native microbial flora that people have in their digestion stages. A "personal footprint" that is set according to diet and lifestyle.
On the one hand, it works to highlight those changes that trigger "in one in three cases" in serious liver disease. On the other, it analyzes quercetin, a natural antioxidant that has beneficial effects on health and is present in foods such as grapes, apples, red onions, blueberries, broccoli, yellow peppers ... We have studied in mice with fatty liver how This natural flavonoid influences and we see that the changes that are associated with dysbiosis do not occur nor do the alterations that can participate in the formation of this disease, "says Francisco Jorquera, head of the Digestive System of the Leon hospital.
Researchers will not only verify that there are microbial irregularities, but that they want to go one step further and create a future treatment tool for this type of pathology so widespread in the developed world.
So far, the multidisciplinary team has detected that there is a certain concentration of pathogens that induce non-alcoholic steatohepatitis. This is a hypothesis backed by the replacement of the Mediterranean diet with the fast-consumption diet.
This, as he exposes, allows progress in knowledge with "much humility." It is an interesting thing about research that each one works from a different focus to discover all the links that participate in the biological process.
If the results are as expected, it could be used as prevention or medication dose. In the first case, diets rich in quercetin would be set up for risk groups, that is, overweight patients, diabetes and hypertension, a "very bad triple alliance" that increasingly affects younger, sedentary and stressful people. "Prevention is cheaper and more useful," he emphasizes. If this antioxidant is shown to have a "special ability" for these patients, a process to validate a medication would begin.
In addition, the University Assistance Complex of Leon will participate in a multicentre and multinational clinical trial to validate the "first major drug" for this "epidemic of the future." 350 research centres around the world will recruit 2,065 patients with non-alcoholic steatohepatitis to demonstrate "the efficacy and safety" of this medication.
Chance will be in charge of setting up three groups. In the first, patients will be given a placebo. In the second, obetolic acid, a drug that in small trials has proven effective in this deadly ailment. And the latter will also receive obetolic acid, but a higher dose. "Some participants are not going to take anything, but it is necessary to show that the drug is more effective than pure chance," says Jorquera.
The completion of the clinical trial is already approved by the hospital's ethical committee and is now in the phase of patient recruitment. It will last three years and half a liver biopsy will be done to the participants to check if the state of health improves. In addition, during the process, they will carry out various tests such as analytical controls. All measures with the same purpose: to verify if it reverses liver fibrosis , which is what characterizes non-alcoholic steatohepatitis. If this circumstance occurs within a year and a half, then the process would be stopped and the medication would be released as soon as possible because its efficacy has now been proven.
Fatty liver is a disease that for many years shows no signs. The problem is that when it does it can be very advanced and the measures to control it are "very inefficient" since the liver is very damaged. At that point, it does show symptoms and these are tiredness, yellow skin ... And what is the alternative? According to the head of the digestive system, only the transplant remains and adds: «There is no treatment for serious liver diseases and the survival of the person depends on their nature.
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