TREATING COVID- 19 THROUGH THE GUT WITH THE QUEEN OF 💩

It is commonly understood that individuals metabolize medications differently based on gender, weight, age and overall health. This means that a drug being tested will work differently based on those traits. But another physiological trait of a person is currently being left out of all clinical trials, creating a flaw in how trials are done: the gut microbiome.

Double blind, placebo, randomized trials are used by the U.S. Food and Drug Administration (FDA) to test the safety and efficacy of new drugs and treatments. But without tracking the gut microbiome of trial participants, the findings don’t tell the whole picture.

“The trials are not truly valid, until we can measure the immunity of gut flora of the patients,” said Dr. Sabine Hazan, a medical doctor, specializing in gastroenterology, internal medicine and hepatology. Her experience includes over 150 FDA authorized clinical trials on pharmaceutical products and 42 self sponsored trials on the microbiome. A trial participant “with a great gut, compared to a person with a gut like a trainwreck cannot be compared. It’s apples and oranges.”

Hazan is the CEO and founder of Ventura Clinical Trials and Progenabiome, and she was on the panel of speakers for the March 2021 Malibu Microbiome Meeting that brought together doctors and researchers to examine the role healthy gut flora play in immunity and health. She spoke about her work and the three active FDA-approved trials on prophylaxis and early treatment protocols for COVID-19.

Microbiome signature

Early on in the pandemic Hazan and her team identified the full COVID-19 genome in the gut of people who were testing positive. This was of particular interest because it confirmed what Hazan expected, that the virus was actively replicating in the gut of those infected and it meant treatment and prevention protocols needed to focus on the gut.

Just like a person’s DNA, the gut flora of an individual not only tells the story of that person’s state of health, it also holds the key to the immune system and how the person will respond to treatment.

Hazan points out that double blind, randomized, placebo trials don’t take into account the individuality of the microbiome. Currently, FDA clinical trials do not have a mechanism for creating different cohorts based on the microbiome,

Dr. Hazan Knows her Sh!T… microbiome diversity (or lack there of) may be the key to identifying those most at risk from COVID-19 something Hazan says is key to truly understanding how the human body is responding to illness, including the SARSCoV-19 virus and any treatment.

Among the trial participants “The microbiome is not at the same level.” She points out that a placebo given to a person with a healthy gut may be able to hold off a serious COVID infection, whereas a one with a compromised microbiome would be susceptible.

She says in her current trials she is “seeing problems in the placebo group. However, it’s not a fair measure.” Because they are unable to do a full genomic sequence of every trial participant’s microbiome, which would allow a true evaluation “of their immune system,” to see their unique gut signature and without seeing what is going on in the gut, a researcher only has part of the information about how the drug is working.

One person she treated, a medical director at a community hospital with a busy medical practice,“super stressed, a high intense person,” just that kind of lifestyle “kills his good bacteria.” He required a certain protocol, whereas his wife, “who is a gardener, and plays in the dirt, is at peace and not stressed…They have different gut microbiomes and different [treatment] results.”

“Clinical trials, in my opinion, should be designed in a different way.” Hazan said the current method, placebo controlled, is “putting patients at risk, it should be done with an open label. I really don’t think placebo control is the best method to analyze this … everyone is different.” And that difference needs to be part of the research.

The health of a person’s gut microbiome can be determined and ranked, with that information being a rubric used along with gender and age in the trial results.

The current FDA trial requirements are “based on the old methods of doing research,” we need to “be changing those methods. I believe we cannot compare two groups unless we first understand the gut.”

She hopes her trials will demonstrate to the FDA the importance of considering the state of a person’s immune system, by assessing the state of the gut microbiome, in determining effective treatments for illnesses across the board.

She points to cases where one family member did not contract COVID while the entire family tested positive. In that family, one person got very very sick. Others experienced symptoms barely worse than a common cold but one person remained negative and asymptomatic the whole time he was exposed to his family who were positive for Covid 19.

The person who didn’t contract COVID went to the same party where his wife contracted the virus. He was around her and 30 people who all con- tracted the infection for a few days yet he never contracted the virus. Why?

Hazan says it’s likely that he has a “super good microbiome, his gut immunity is stronger. This is the basis of my research. Understanding what makes his microbiome able to be in a party with COVID. Sleeping in the same bed with his wife, who had COVID…and he never gets contaminated, compared to someone else who gets it after a short exposure.”

She believes that a person’s “microbiome signature” is what protects them from contracting, getting seriously ill, dying from or surviving SARS-CoV-2.

“We are testing everyone’s microbiome before and after. So when we look at the placebo group we can get at the question of why did this person crash? Was there something in the microbiome?”

Keeping doctors independent

Hazan’s research is self funded. Ventura Clinical Trials does not have the backing of any pharmaceutical company or foundation for the work they are doing related to COVID.

Separate from those who are participating in the trials, Hazan is treating hundreds of patients off-label with treatment protocols that may include hydroxychloroquine and Ivermectin, azithromycin, doxycycline, along with vitamins C, D and Zinc.

Many of the patients coming to her for treatment were unable to get treatment from local doctors or hospitals. Hazan is seeing strong pushback from hospitals due to the off-label use of these medications, even though they have been in use for decades, treating thousands of people safely for other illnesses.

A major hurdle in getting early treatment to patients is the lack of local doctors understanding the approach.

“I’m trying to shake them up. By the time the treatment protocols being tested today are accepted guidelines, it will be two, three, five years. Maybe COVID will disappear by then, maybe it will become stronger.” She says that many doctors are hamstrung by the “guidelines. They are not practicing the art of medicine, they are practicing the guidelines. Maybe that saves you from a lawsuit, but it doesn’t save the patient.”

Hazan and other doctors around the country are comfortable treating patients off-label, at home and early on for COVID. “In our aim to protect the patient we have lost the patient,” and the tendency of “not trying new treatment options allows for death of the patients. Ultimately, if we do not try and we don’t push we’ll never find answers.” The answers are within us and we must be brave enough to try for the sake of the patients but for the sake of survival of humanity. The “right to try” (when patients are begging for investigative products) is an integral part of medicine and one that remains part of the patient-doctor relationship but also part of informed consent. Informed consent protects the patients and the doctor and allows for investigative products to be attempted in a new virus that has killed hundreds of thousands of people.