Treating Mold-Related Illness: The Shoemaker 12-Step Protocol

My Mold Story.

Many people don't know this about me. In 2018, my wife and I worked with a well-respected builder to design and build our dream home. One night I was awoken by a dripping sound in the entry to our bedroom. I woke up to find water dripping from a can light in the ceiling. The air conditioning people did not properly hook up the drip-pan overflow float switch, and water poured into our ceiling. The builder said they fixed the problem. However, that was far from the truth. Being naive to the world of water-damaged buildings, I had no idea that the real problem had just begun and that my life was about to change. Over the following 24 months, I went from a healthy, vibrant, hard-working husband, father, doctor, public speaker, and business owner to a chronically sick, congested, short of breath, anxious, suicidal, worthless human with heart palpitations, excessive urination, yeast infections, tinnitus, headaches, sinus, and tooth pain and pressure, who lost 55 lbs due to anorexia and developed a maxillary fungal cyst. I had no idea why this happened because I never put "2 and 2 together" until someone suggested assessing for mold. That was an EUREKA moment!

So, even though I am a concussion specialist, I have a special place in my heart dedicated to educating people about my journey back to health. The Shoemaker Protocol was pivotal in my victory over CIRS.

**Disclaimer:**

This article is intended for educational purposes only and describes the Shoemaker Protocol, which has demonstrated significant success in treating individuals suffering from health consequences due to exposure to mold and mold toxins. It is important to understand that the content provided here is not intended to direct or dictate care for any individual.

Mold-related illness, particularly Chronic Inflammatory Response Syndrome (CIRS), is a complex and challenging condition. The symptoms and health impacts associated with mold exposure can vary greatly among individuals, requiring a personalized and professional approach to diagnosis and treatment.

If you are experiencing symptoms that you believe may be related to mold exposure, suspect that you have been exposed to mold, or are seeking ways to improve your health in relation to mold illness, it is crucial to consult with a licensed health practitioner. Ideally, this practitioner should be trained or certified in the Shoemaker Protocol, as they will have the specific knowledge and expertise to guide you through the appropriate steps of diagnosis and treatment based on your unique health situation.

Remember, the information provided in this article is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or health concerns. Never disregard professional medical advice or delay in seeking it because of something you have read in this article.


The 12-Step Shoemaker Protocol

The Shoemaker Protocol is a comprehensive and systematic approach designed to treat mold illness, also known as Chronic Inflammatory Response Syndrome (CIRS). This condition is caused by exposure to molds, mycotoxins, water-damaged structures, or infections and involves a complex array of symptoms due to the body's prolonged inflammatory response to biotoxins, particularly mold. Dr. Ritchie Shoemaker, a pioneer in the field of biotoxin-related illness, developed this protocol. It is analogous to climbing a ladder, where each step must be followed in sequence to treat the illness effectively. The protocol's success hinges on strict adherence to its steps, as deviations or substitutions have been shown to compromise its effectiveness.

Testing for CIRS

The Shoemaker Protocol distinguishes itself by not being primarily guided by symptoms or exposure history. Instead, it is meticulously data-driven, relying on various laboratory tests to inform its action. Before embarking on this protocol, Dr. Shoemaker recommends a CIRS screening that takes about 15 minutes and costs $15, and consists of a questionnaire and a visual contrast sensitivity test. Dr. Shoemaker says that this questionnaire, combined with the VCS test is very sensitive for CIRS. If the test comes back positive, you should proceed with the protocol. If it comes back negative, you should still consult with a provider, but you are less likely to suffer from CIRS.

Before commencing the Shoemaker Protocol, it is imperative to undertake a thorough metabolic evaluation, encompassing a suite of tests, some of which are quite rare and specialized. Dr. Antonucci provides an insightful overview of what constitutes a comprehensive metabolic work-up on his Functional Blood Chemistry page. Complementing this extensive metabolic assessment and physical examination, the Shoemaker Protocol requires a set of additional laboratory tests:

Labs that can be run by most high-complexity laboratories (Quest, LabCorp, etc):

  • HLADR B1,3,4,5 Testing
  • Melanocyte Stimulation Hormone (MSH) Levels
  • TGF-B1 Levels
  • Component 3a (C3a) Levels
  • Component 4a (C4a) Levels
  • Metallomatrix Protein 9 (MMP9) Levels
  • Lipase
  • VEGF, Plasma Levels
  • Anti-Gliadin Antibodies
  • Adrenocorticotropin Hormone w/ Simultaneous Cortisol Levels
  • Anti-Diuretic Hormone Levels w/ Osmolality
  • Vasoactive Intestinal Peptide (VIP) Levels

Specialty Labs:

These labs typically range from $2,000-3,000, depending on the lab. Most of them WILL NOT be covered by your insurance.

The results of these labs will allow your doctor to understand if you have CIRS, how severe your case is, your risk of re-exposure or relapsing, and your genetic susceptibility. It will also serve as a baseline to measure the success of the Shoemaker Protocol.

Step 1: Avoiding Mold Exposure

The initial step in the Shoemaker Protocol is the complete removal from mold exposure. This is foundational because ongoing exposure can undermine the entire treatment process. Patients are advised to leave environments that are contaminated with mold, including workplaces, schools, or homes. How would someone know if their environment is contaminated? There are several different types of tests to evaluate environmental levels of mold.  Identifying and eliminating the source of mold exposure is akin to stopping the influx of water into an overflowing bathtub. Without addressing the root cause, the rest of the treatment efforts can be futile.

Step 2: Administration of Cholestyramine (CSM) or Welchol

Mycotoxins, due to their lipophilic nature, tend to bind to cholesterol in the body. This characteristic makes cholesterol a carrier for these toxins, facilitating their persistence and circulation within the body. To combat this, one strategy involves the use of cholesterol-lowering medications. These medications function by inhibiting the body's cholesterol production, thereby reducing the overall cholesterol available for mycotoxins to bind to. Additionally, some of these drugs can enhance the liver's ability to process and eliminate cholesterol, which can help detoxify by reducing the burden of mycotoxin-bound cholesterol in the system. This approach is a key component in managing the effects of mycotoxin exposure and mitigating their impact on health.

So, the next stage involves using Cholestyramine (CSM) or Welchol, bile acid sequestrants. Unlike statins, which inhibit the liver's cholesterol production, or fibrates, which primarily affect triglyceride levels, Cholestyramine and Welchol are bile acid sequestrants. Unlike statins and other cholesterol medications with systemic effects (involving the whole body), bile acid sequestrants work locally in the gut. They are not significantly absorbed into the bloodstream, which makes their side effect profile different from systemic cholesterol medications. These medications bind to the biotoxins in the gastrointestinal tract, preventing their reabsorption and facilitating their elimination from the body. Regular monitoring and testing are crucial to determine the effectiveness of these medications.

Individuals who are either not tolerant or candidates for CSM or Welchol can speak with their doctor about trying Modified Citrus Pectin (MCP) supplements. They don't work the same way (MCP detoxifies through chelation of heavy metals in the guy); they are a less effective substitute for an individual that cannot utilize a bile acid sequestrant.

Step 3: Eradicating MARCoNS

MARCoNS (Multiple Antibiotic Resistant Coagulase Negative Staphylococci) are bacteria that can colonize the nasal passages of individuals with mold illness. These bacteria create a biofilm that protects them from many antibiotics.

Prominent experts in mold and biotoxin-related illnesses often recommend using a specially formulated BEG nasal spray for treating MARCoNS infections in the sinuses. This condition is known for its biofilm-forming capabilities and resistance to antibiotics. BEG nasal spray is particularly beneficial for individuals with a positive MARCoNS sinus culture and is tailored to support those recovering from sinus infections and biotoxin-related health issues.

Research in laboratory settings has underscored the effectiveness of BEG in combating antibiotic-resistant bacterial colonies. This approach is crucial in facilitating affected patients' recovery and healing process. The effectiveness of the BEG nasal spray is attributed to its combination of active ingredients: Bactroban (mupirocin) and Gentamicin, which are antibiotics, along with Edetate Disodium (EDTA), a calcium chelator. Originally, BEG was the combination nasal spray developed by Dr. Shoemaker for addressing MARCoNS featuring this specific blend.

However, physicians have begun to adapt and modify this initial formula over time. These variations often involve altering the antibiotic component, with some opting for levofloxacin, or by incorporating extra ingredients into the mix. For instance, the antifungal medication itraconazole is occasionally added, creating a variant known as BEL nasal spray. The primary objective of these nasal sprays remains consistent: to effectively target and eliminate the tough bacterial colonies residing in the sinus cavities. This targeted approach renders these sprays an integral part of the treatment regimen for MARCoNS infections.

Step 4: Addressing Gluten (and other food) Sensitivity

Many patients with mold illness exhibit gluten sensitivity, indicated by antigliadin antibodies. If Celiac Disease is ruled out, a gluten-free diet is prescribed for a trial period of 2-3 months, followed by retesting. If Celiac Disease is confirmed, the individual must abstain from gluten for life. If the antibody levels normalize, gluten may be reintroduced into the diet. Some individuals may have multiple food sensitivities besides or in addition to gluten. Based on your dietary habits and choices, your doctor may elect to run testing for multiple food sensitivities. An elimination diet of the foods indicated for 2-3 months, is imperative to reduce systemic inflammation and restore the integrity of the gut barrier system, which is often destroyed by mold and mycotoxin inflammation. The relationship between gluten and other food sensitivities and CIRS is complex and intertwined with immune dysregulation, gut health, and the body's inflammatory and detoxification responses. Addressing food sensitivities is often an important aspect of managing and treating CIRS to reduce overall inflammation and support the healing process.

Step 5: Normalizing Sex Hormones

Abnormal sex hormone levels are common in mold illness, often due to chronic stress and inflammation, causing hypothalamic-pituitary dysregulation. Inflammation, a hallmark of CIRS, can upregulate aromatase expression in various tissues. This is particularly notable in adipose (fat) tissue. Aromatase is an enzyme that converts testosterone to estrogen. In men, this might manifest as symptoms of estrogen dominance, such as gynecomastia (enlarged breasts), emotional disturbances, or decreased libido. In women, it can exacerbate conditions like premenstrual syndrome or contribute to hormonal imbalances. Elevated estrogen levels also have correlations to cardiovascular disease, breast cancer, and other health conditions.

By performing a comprehensive hormone assessment, a trained physician can untangle and find the root cause of the sex hormone dysfunction; whether it be pituitary suppression, cortisol-related stress responses, inflammation, or aromatization. Treatments may include supplementing with DHEA, HCG injections, Clomid administration, or VIP (vasoactive intestinal polypeptide) nasal spray. The goal is to balance hormone levels, which are crucial in the body's response to inflammation and stress.

Step 6: Balancing ADH/Osmolality

ADH is a hormone produced by the hypothalamus in the brain and stored and released by the pituitary gland. It plays a critical role in regulating the body's retention of water and maintaining osmotic balance. In individuals with CIRS, one of the common findings is a reduction in ADH levels. This reduction can be a response to the inflammatory cytokines and other biotoxins produced by mold. When ADH levels are low, the kidneys do not reabsorb as much water, leading to increased urine production and potentially dehydration. The decrease in ADH levels can lead to a condition known as diabetes insipidus, which is characterized by excessive thirst (polydipsia) and excessive urination (polyuria). This can disrupt sleep due to the need for frequent urination during the night and can lead to dehydration if fluid intake doesn't compensate for the loss. ADH helps regulate the concentration of solutes in the blood (osmolality). In CIRS, the dysregulation of ADH can lead to an imbalance in osmolality, contributing to symptoms like fatigue, headaches, and confusion.

This step involves correcting antidiuretic hormone (ADH) and osmolality issues. An imbalance in ADH can lead to problems with fluid retention and concentration. Treatment typically includes the administration of desmopressin tablets every night for 10 days, with close monitoring of osmolality levels.

Step 7: Regulating MMP-9 Levels

Matrix Metalloproteinase-9 (MMP-9) is an enzyme that plays a crucial role in the body's physiological and pathological processes. It belongs to the matrix metalloproteinases (MMPs) family, which are involved in the breakdown of extracellular matrix proteins. MMP-9, in particular, is key in the remodeling of the extracellular matrix, a fundamental aspect of cellular protection, repair, and development. However, its role extends beyond normal physiological processes and is significant in various pathological conditions. Elevated levels are associated with cancer, cardiovascular disease, neurological disorders, and autoimmune conditions.

Elevated levels of MMP-9, are often found in patients with mold illness. The protocol recommends supplementing with omega-3 fatty acids and adhering to a No-Amylose diet to lower these levels.

This diet avoids foods high in amylose, such as: Rice, Corn, Wheat, Beans, Lentils, Potatoes, Peas, Pastas, Barley, etc.

Many supplements and lifestyle modifications can help lower MMP-9 levels, though. Regular exercise, avoiding smoking and alcohol, and managing stress have all been shown to decrease MMP-9 levels.

Zinc, resveratrol, molecular hydrogen, foods high in polyphenols and antioxidants (berries, green tea, dark chocolate, and red wine in moderation), statin medications, and tetracycline antibiotics have also demonstrated the ability to reduce MMP-9 levels.

Step 8: Correcting Low Vascular Endothelial Growth Factor (VEGF)

Vascular Endothelial Growth Factor (VEGF) is a signal protein that plays a crucial role in angiogenesis, the formation of new blood vessels from existing vasculature. It is essential in both normal physiological processes, such as wound healing and embryonic development, and in pathological conditions, including cancer and age-related macular degeneration. VEGF stimulates the growth of blood vessels by binding to specific receptors on the surface of endothelial cells, which line the interior of blood vessels.

In mold illness, low levels of VEGF can cause cognitive and physical symptoms and impede recovery. The protocol addresses this through dietary modifications and omega-3 supplementation, similar to the approach for MMP-9 regulation. But other interventions can also help increase VEGF, such as hyperbaric oxygen therapy, high-altitude training, increasing nitric oxide levels, molecular hydrogen, exercise (especially HIIT programs), breath-holding/breath-work and more.

Step 9: Lowering Elevated C3a

Complement Component 3a is a key player in the immune system, particularly in driving inflammatory responses. Its regulation is crucial for maintaining immune balance and preventing overzealous inflammatory reactions that can damage tissue and contribute to various pathological conditions. Elevated C3a levels are a concern in mold illness, suggesting persistent inflammation.

The protocol involves using high-dose statins to reduce C3a levels. To prevent potential CoQ10 deficiency, which can be a side effect of statins, CoQ10 is co-administered, starting 10 days before the statins. Additionally, improving sleep patterns, avoiding smoking and alcohol, increasing fiber intake, exercising, reducing stress, and supplements like omega-3 fatty acids, curcumin, and Vitamin D, can all help lower C3a

Step 10: Managing Elevated C4a

Complement Component 4a is another innate immune system response marker and can be elevated in mold illness. It provides insight into the severity of a patient's condition. The protocol previously included Procrit/Epoetin alfa for this purpose. However, due to regulatory changes and the risk of clotting using erythropoietin, the focus has shifted to other aspects of the protocol, including administering vasoactive intestinal peptide (VIP).

Step 11: Reducing Elevated Transforming Growth Factor Beta 1 (TGFB1)

TGFB1 is another crucial marker of immune system activity and the severity of mold illness. Other elements of the Shoemaker Protocol (Steps 7-10) will reduce TGFB1. However, resiliently-elevated levels are addressed with a 30-day administration of Losartan, a medication commonly used to treat high blood pressure, which has been found to reduce TGF-β1 levels. Losartan belongs to a class of drugs known as angiotensin II receptor blockers (ARBs), which can modulate the effects of TGF-β1.

During this treatment, patients must monitor for symptoms like low blood pressure and redraw abnormal labs upon completion of therapy. Patients with hypotension may use the alternative medication, pentoxifylline. This drug, used for treating muscle pain in people with peripheral artery disease, has also been shown to decrease TGF-β1 levels. It's believed to have anti-inflammatory and immunomodulatory effects.

Step 12: Using Vasoactive Intestinal Peptide (VIP)

The final step involves using VIP, critical in restoring immune balance and regulation. Vasoactive Intestinal Peptide (VIP) is a neuropeptide that plays a multifaceted role in the human body. It functions as a neurotransmitter and a hormone, influencing various physiological processes. VIP is known for its ability to relax smooth muscles, dilate blood vessels, and lower blood pressure, hence the name "vasoactive." It's found in the brain, gut, pancreas, and other organs and regulates intestinal movements and secretions. VIP also plays a role in the immune system, which acts as an anti-inflammatory agent, and in the respiratory system, where it helps regulate airflow and bronchial relaxation. Additionally, it has neuroprotective properties and is involved in regulating circadian rhythms.

For VIP treatment to be effective, certain criteria must be met: normal or slightly elevated blood pressure, normal lipase levels, a negative culture for MARCoNS, a normal HERTSMI-2 score (indicating a safe living environment), and a normal Visual Contrast Sensitivity (VCS) test. VIP treatment is particularly beneficial for cognitive symptoms related to mold exposure.

Ancillary, Ongoing, Supportive Interventions to Increase Success

As its name suggests, a profound inflammatory response is at the heart of Chronic Inflammatory Response Syndrome (CIRS). This cascade of inflammation has far-reaching effects, with inflammatory messengers potentially influencing the hypothalamus. Such an impact can lead to alterations in autonomic neurological functions, encompassing aspects like blood circulation, heart rate regulation, stress response mechanisms, digestion, and more. Additionally, it can disrupt hormonal balances, energy production, and sleep patterns, among other vital bodily processes. The role of mycotoxins and other biotoxins is particularly insidious, as they can severely disrupt critical bodily pathways, including those responsible for methylation, antioxidant defense, and detoxification.

In light of these complexities, adopting passive treatment modalities specifically targeting inflammation and blood flow could significantly augment the effectiveness of the Shoemaker Protocol. These approaches aim to mitigate the core issues of CIRS, offering a more comprehensive strategy in managing and overcoming this challenging condition.

Some examples of these supportive interventions include:

  • Hyperbaric Oxygen Therapy
  • Pulsed Electromagnetic Field Therapy
  • Molecular Hydrogen
  • Methylation and Sulfiation Support
  • Photobiomodulation/Infrared Saunas
  • Cold Plunges
  • Pre- and Probiotics
  • Vagus Nerve Stimulation

Ongoing Monitoring and Exposure Management

It's crucial to monitor for any new exposure to water-damaged buildings or mold throughout the treatment process and even after its completion. A re-exposure can necessitate starting the protocol from the beginning. Therefore, preventive measures against water damage and mold are emphasized.

The Shoemaker Protocol: Education and Certification

The Shoemaker Protocol is a treatment method and an educational tool. Dr. Shoemaker has developed certification programs for physicians, including the Proficiency Partners Certification and the Shoemaker Protocol Certification Program. These programs aim to equip practitioners with comprehensive knowledge and skills to implement the protocol effectively.

The Role of the Shoemaker Protocol in CIRS Treatment

The Shoemaker Protocol represents a holistic and multifaceted approach to treating mold illness. Its systematic nature ensures that each aspect of the illness is addressed. By following the protocol's steps, patients can experience significant improvements in their symptoms and overall health. The protocol also underscores the importance of understanding mold illness as a complex and multifactorial condition that requires a structured and disciplined approach to treatment.

In summary, the Shoemaker Protocol offers a detailed and step-by-step framework for treating mold illness, emphasizing the importance of meticulous adherence to its guidelines. Its success hinges on a comprehensive understanding of the condition, individualized patient care, and ongoing management to prevent re-exposure and recurrence of symptoms.

Dr. Antonucci
Dr. Matthew Antonucci
Doctor | Educator | Researcher
Dr. Antonucci is an experienced chiropractic neurologist, board certified in functional neurology and multiple sub-specialties, a researcher, and an international lecturer, currently seeing patients out of Minneapolis, MN. He trained extensively under Prof. Frederick R. Carrick, maintains an active private practice with licenses in multiple states, and has provided breakthrough neurorehabilitation and performance training to thousands of patients. He consults with several NFL and NHL franchises on performance training and concussion. His work has been featured on ESPN, Sports Illustrated, CBS, Fox News, and more. He has delivered more than 11,000 hours of presentations, both nationally and internationally, on behalf of the Carrick Institute. Most importantly, he is a loving husband and the father of five amazing boys, whom he hopes to inspire to follow in his footsteps.

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