Physician Outlook

Microbiome Signature


Treating Covid-19 Through The Gut With The Queen Of Sh##

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(1). 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, something Hazan says is key to truly understanding how the human body is responding to illness, including the SARS-CoV-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 contracted 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. 

DEK//The Bassham Family, Havasu, Arizona

“I was imploring everyone to be careful,” said Rebecca Bassham, BS, RT, BCN, QEEG-T, who is triple board certified and works as a psychophysiologist studying “people’s brains from the inside out. Her husband Ty Bassham, travels extensively for work related to their family owned radiology business. They split their time between homes in Arizona and Nevada.

Early in the pandemic, March 2020, Ty was traveling in the region for work and she was concerned. “There were no masks to be found anywhere.” She wanted him to be careful but also didn’t really expect them to get sick. Both are 57. “We’re healthy, we exercise, eat well. We figured we’re not going to get it. We’re fine.”

But a couple of weeks later on Sunday, March 29, 2020, Ty woke up feeling unwell and by noon “it hit him like a ton of bricks.” He was coughing all day. “He was on the couch all day, it was unlike him.” That night in bed he had fever, chills, body aches, coughing, “and anytime he ate or drank it felt like it was burning,” in his gut. “He wasn’t drinking water, I couldn’t get him to eat.”

Rebecca took Ty to urgent care Monday morning. At that time in Havasu, AZ “they had very limited testing, Only three or four tests available every day.” The tests were only being given to those with symptoms. Ty got tested. They found out on Wednesday he was positive. Urgent care gave him azithromycin and told him to take Advil for the body aches.

Their daughter, Cheyanne, 24 had similar symptoms but with more respiratory issues. She had a history of asthma, and tested positive. “We were really concerned.” Their son Aaron, 28, got sick the next day, with the same symptoms. Medical officials declined to test Aaron, in order to save supplies, they said they know he’s positive and it would be a “waste.” Rebecca said both Aaron and Cheyanne recovered after a few days.

And the whole family, “They all lost their sense of taste and smell.” All except Rebecca. Ultimately she would be tested 20 times, all would be negative. She has also tested negative for antibodies.

Ty was not improving. He was having trouble breathing and Rebecca was worried about dehydration because she couldn’t get him to drink any fluids. They were able to get nurses with the company Destination Hydration to come to their home to administer two bags of IV fluids to Ty on their patio. This helped but he was still declining.  His oxygen saturation hovered around 90 and his temperature was a low grade fever at 100.

“The ZPAC [azithromycin] didn’t touch the symptoms,” said Rebecca. Ty lost 21 pounds in 10 days.  His pulse ox didn’t go below 90, his low grade fever hung on at about 100.

Through a doctor she knew in New Jersey she was connected to Hazan for treatment. Hazan sent a prescription for hydroxychloroquine and also started Ty on Vitamin C, D and Zinc and began checking in on him regularly over the phone.

But at that time no Arizona pharmacies were filling prescriptions for the drug to treat COVID out of the hospital. They eventually found a doctor friend who had some and sent her the prescribed amount. They received it 10 days after the onset of symptoms. Ty immediately took the first dose.

“Within five hours it was a whole new experience,” said Ty. “A big turn around. I felt more normal. I healed from that point on. I wasn’t tired, I just felt like my normal self. Fear was dropping, body aches went away. I was able to start taking fluids and eating food.”

On Day 12, just two days after taking the medication his fever broke. Normally the early treatment protocol should be started within 5 to 6 days of symptom onset.

Ty said he wasn’t nervous at all about taking the drug for the off-label use. “At that point in time what was my alternative? Take it, maybe have some bad side effects or I’d be dead from COVID.”

At the same time Ty was being treated off-label by Hazan, Rebecca, still negative, joined the prophylaxis clinical trial with Ventura Clinical Trials. She was caring for her husband. He was not able to self isolate while he was sick because he needed her care. She was constantly exposed to active virus, and never got sick.

Rebecca is convinced that Ty “would be a dead man, he wouldn’t have lived,” without the medication that caused the shift in his illness. And as for her not getting sick at all?

“I just refer to myself as a Jedi, unexplainable protection against the forces of evil.” Or maybe there’s something in her gut.

DEK//The Billings Family: Huntsville, Alabama

In early November, a few days into a 14-day quarantine after being notified that she had been exposed to a person who tested positive for  SARS-CoV-2, Amy Billings noticed a smoothie she was drinking had no flavor.

“That is not good. I went around my house smelling candles. I had lost taste and smell.”  That was early on a Saturday, but that night she was feeling “really strange.” Thinking back she had chest tightness the night before, but she had “brushed it off.”

Billings is a pediatrician and works part time in a pediatric emergency unit at the local hospital. She also does hormone balancing work at a local wellness center.

Saturday night “was really intense. I had lower back pain, body aches,” She was taking Motrin every few hours for the aches. “That pain would wake me out of sleep.” She was sleeping with a heating pad. “The chest tightness got worse.”

She had been in touch with Hazan through a Facebook group and the next morning called her. “I’m not going to sit here and do nothing and chance this going really badly.” She told Hazan about her exposure and the symptoms. “It was feeling like I had been hit by a truck. She said ‘you’ve got COVID, let’s get you treated.”

In the next 24 hours she declined quickly and began having difficulty breathing. Hazan called in an Ivermectin prescription to a local pharmacy in Alabama and it proved challenging to find a pharmacy willing to fill a hydroxychloroquine prescription. Billings’ oxygen saturation was at 90 or 91.

After starting both medications, within 24 hours “as crazy as it sounds I started to feel better. Every day I got better and better.”

Her husband, Julian Billings, a gastroenterologist started on Hazan’s prophylaxis protocol. He never got sick and tested negative.

“What saddens me more than anything with this pandemic is every story I hear of someone who dies...could they have been saved if they had taken outpatient treatment?” said Billings. “Are we going to learn one day that a lot of these deaths could have been prevented? It shoots to my core of who I am as a physician, as a human being...Medicine is an art, it is not absolute. As doctors we grow from each other's knowledge. In a pandemic the medical community above all should have been coming together. Saving lives is why we went into medicine.”

Register for The Malibu Microbiome Meeting featuring Dr. Sabine Hazan, including Dr. Thomas Barody, Dr. Neal Stollman, Dr. Colleen Kelly, Dr. Howard Young and more on March 20, 2021 online at: www.malibumicrobiomemeeting.com

1. Papoutsis, A., Borody, T., Dolai, S. et al. Detection of SARS-CoV-2 from patient fecal samples by whole genome sequencing. Gut Pathog 13, 7 (2021). https://doi.org/10.1186/s13099-021-00398-5: Online at: gutpathogens.biomedcentral.com/articles/10.1186/s13099-021-00398-5

For more information on the three active trials being conducted by Ventura Clinical Trials visit:

1. Trial testing hydroxychloroquine, azithromycin with Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04334512

2. Trial testing hydroxychloroquine, Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04335084?term=ProgenaBiome&recrs=ab&draw=7&rank=37

3. Trial testing ivermectin, hydroxychloroquine, doxycycline and Vitamin C, Vitamin D and Zinc: https://clinicaltrials.gov/ct2/show/NCT04482686?term=ProgenaBiome&recrs=ab&draw=7&rank=39

Kimberly Rivers is a staff reporter/photographer for a weekly paper in Ventura County, CA covering health, local government, the environment, and other local news. She covers wide ranging topics as a freelance writer for national publications. She can be contacted via email at kimberly.rivers@gmail.com on Twitter @kimriversojai.

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