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Treatment of Biotoxin illness

The Shoemaker Protocol: Treatment for Biotoxin Illness

Step 1: Removal from Exposure

The first and most important step is for the patient to be removed from the source of exposure! The other steps in the protocol will not be effective if the patient is experiencing repeated exposure. Water damaged buildings and the biochemical stew found inside are the most common source of exposure for CIRS patients. (For additional information on the biochemical stew found in water damaged buildings, see Appendix 1).

NIOSH (National Institute for Occupational Safety and Health) estimates that up to 50 percent of all American buildings have water damage. Sources of water damage can come from slow leaking pipes, poor fitting drains, poorly ventilated crawl spaces, water intrusion in the basement and roof leaks to name just a few.

To determine whether your home or workplace has been water damaged, testing by an accredited lab like Mycometrics is required. Mycometrics uses MSQPCR (Mold-Specific Quantitative Polymerase Chain Reaction) analysis, also known as Environmental Relative Moldiness Index (ERMI) or its derivative HERTSMI-2 (Health Effects Roster of Type Specific [Formers] of Mycotoxins and Inflammagens, second version). ERMI tests for over thirty types of mold while HERTSMI-2 tests for the five types of mold most commonly involved in CIRS.

If ERMI or HERTSMI-2 tests indicate water damage has occurred, an indoor air quality specialist (IAQ) should be consulted in order to diagnose the cause of water damage and help ensure proper remediation.

Step 2: Removal of Biotoxins

CSM (cholestyramine) is a non-absorbable polymer resin that has been FDA-approved for use in lowering cholesterol. Due to its chemical structure, CSM has a net positive electrical charge which attracts and binds negatively charged biotoxins.

In CIRS patients, when the liver secretes bile during digestion, the bile contains some of the biotoxins. Before starting CSM, the biotoxins in the bile are reabsorbed in the intestine and cycled back to the liver during the normal bile circulation process. Once the patient has started taking CSM, it binds the biotoxins as described above and then carries them out through the stool, stopping them from being reabsorbed and cycled back to the liver. Over time, CSM removes more and more biotoxins from the body. CSM must be taken on an empty stomach or between meals. The typical dose of CSM is 4 mg four times daily. CSM can cause constipation, bloating, acid reflux, and heartburn.  Supplementation with magnesium can help ease the symptoms of constipation.

In patients that are unable to tolerate CSM due to it’s  gastrointestinal side effects, Welchol might be used. Like CSM, Welchol is a bile acid binding resin, but it has fewer side effects.  Welchol is less effective than CSM because it only has 25 % of the binding sites found in CSM. Hence, it will take longer to normalize lab values and symptoms when treating with Welchol, compared to CSM.

In his research, Dr. Shoemaker tried other binding agents such as cholestipol, charcoal, clay such as bentonite, chitosan, and pectin.  Unfortunately, he has not seen the same change in lab values using these binders.

Treatment with CSM or Welchol must be continued for a minimum of 30 days and until the patient’s VCS score has normalized.

Step 3: Treat MARCoNS

After the first month of treatment with CSM, patients whose nasal culture tested positive for MARCoNS (Multiple Antibiotic Resistant Coagulase Negative Staph) need to be treated until colonization is gone. MARCoNS secrete toxins that lower MSH (Melanocyte Stimulating Hormone), produce substances that destroy red blood cells (hemolysins), and raise cytokine levels. A nasal spray called BEG (Bactroban/EDTA/Gentamicin) is used to destroy MARCoNS. Bactroban and Gentamicin work together against the MARCoNS while EDTA dissolves the protective biofilm that the bacteria produces. Biofilm is a slime-like substance created by bacteria to help them attach to a surface, stick to each other to form colonies, and to protect themselves from immune attack or antibiotics. The biofilm created by the MARCoNS bacteria is part of what creates its antibiotic resistance. When first beginning treatment for MARCoNS, some patients may feel their symptoms get worse in the beginning. The reason is because as the biofilm is broken down, the encased bacteria is exposed along with its toxins, resulting in a temporary increase in toxin levels.

MARCoNS and Your Dog

In Dr. Shoemaker’s research, he discovered that dogs can also be carriers of MARCoNS. Cats, however, are not MARCoNS carriers and are unaffected by it.

MARCoNS treatment continues for 30 days, followed by a new nasal culture test to make sure the MARCoNS colonization is gone. If the culture is still positive for MARCoNS after the first 30 days of treatment, other sources must be investigated.  A few sources of continued MARCoNS exposure include the family dog, infected root canal teeth, or a deep-seated jawbone cavitation (weakened area of the jawbone that harbors bacteria, eventually killing the bone tissue and leaving enclosed spaces of decomposing bone and teeming with bacteria). A biological dentist will often need to be consulted regarding any suspected infections in root canal teeth or potential cavitations.

Step 4: Correction of Anti-Gliadin Antibodies

In patients with biotoxin illness who have low MSH, there is an increased risk of inflammation and autoimmune disease. If those patients also have high levels of Anti-Gliadin Antibodies, they need to remain on a gluten-free diet for at least three months, potentially longer. These patients should also be evaluated for celiac disease.  

Step 5: Correction of Androgens

Patients with biotoxin illness often develop an imbalance of their androgen-based hormones, such as dehydroepiandrosterone (DHEA) and testosterone. Current research suggests this imbalance could be caused by an increase in an enzyme called aromatase, which changes testosterone to estradiol (a form of estrogen). Recommended treatment would be supplementation with high quality DHEA or human chorionic gonadotrophin (HCG). Vasoactive Intestinal Peptide (VIP) treatment could be considered at this step to stabilize the aromatase enzyme.

Step 6: Correction of ADH/Osmolality Dysregulation

Desmopressin (DDAVP) is a synthetic form of ADH (Anti-diuretic Hormone) that helps correct water loss and dehydration for patients with biotoxin illness. DDAVP is available as a nasal spray or tablet medication. Blood serum osmolality (concentration of chemicals in blood serum or plasma) and blood sodium levels need to be monitored with extreme caution while on this medication.

Step 7: Correct MMP and VEGF

The treatment to correct MMP and VEGF depends on the patient’s leptin level. If the patient’s leptin level is less than 7, supplementing with high dose Omega-3 fatty acids (2.4 gm EPA and 1.8 gm of DHA) works to correct the imbalance. If the patient’s leptin level is higher than 7, the patient may be prescribed Actos (45 mg once daily) for 30 days. Actos may cause low blood sugar and also has a black box warning of increased risk of bladder cancer with long term use.  

Patients must strictly follow a low amylose diet during this step of the protocol. Amylose is a type of starch made of long chains of glucose (sugar). The diet calls for avoiding many starches and forms of simple sugars. See Appendix 2 for a list of foods to eliminate while on a low amylose diet.

Step 8: Correct C3a

For patients with high C3a levels, the immune system is being triggered by cell membranes in the presence of microbes that cause Lyme disease. The primary Lyme infection needs to be treated with antibiotics as appropriate before moving to the next step in the protocol. The patient will also be prescribed a high dose cholesterol medication (often Zocor 80 mg) along with a CoQ10 supplement.

Step 9: Correct C4a

C4a is biomarker that shows how severe the patient’s case of CIRS is. Treatment with erythropoietin (Procrit) reduces C4a. Procrit has a black box warning due to increased risk of blood clots. The decision whether or not to use Procrit is based on individual patient assessment and requires close monitoring, extreme caution, and the patient’s informed consent. If Procrit cannot be used, then VIP should be considered.

Step 10: Correct TGF beta-1

Cozaar (Losartan) can be used to lower TGF-beta-1 and decrease the risk of autoimmune response and illness. Patients with low blood pressure who cannot take Cozaar should be considered for VIP treatment at this step instead.

Step 11: Vasoactive Intestinal Peptide (VIP)

Vasoactive intestinal peptide (VIP) is a 28 amino acid regulatory neuropeptide with many beneficial physiological effects. In his research, Dr. Shoemaker noted low levels of VIP in 98 percent of the patients with biotoxin illness. In contrast, only 10 percent of control patients had low VIP levels.  

VIP restores regulation of the inflammatory processes that have gone awry in biotoxin illness. It also normalizes genomics, down regulates aromatase (enzyme that converts testosterone to estrogen), lessens chemical sensitivities, releases endorphins, and reduces the “sicker-quicker” phenomenon. The “sicker- quicker” phenomenon occurs in some patients following re-exposure to water damaged buildings. VIP is thought to be involved in down regulating C4a production, which may be the key to reducing the “sicker-quicker” phenomenon.

VIP treatment is the very last step in the Shoemaker protocol. By this time, most patients already feel much better but some will require this last step in the protocol. Before starting VIP treatment, all of the prior steps of the protocol must have been completed successfully. Also, it is critical to make sure the VCS test is normal, MARCoNS culture is negative, and in the case of water damaged buildings, that the source of exposure has been successfully remediated (ERMI result is less than 2 or HERTSMI-2 result is less than 10). If all the steps of the protocol are not completed and if there is ongoing exposure to WDB, the VIP treatment will not work.  

If all of the above conditions are met, VIP treatment can begin. VIP administration should be followed by the prescribing doctor. First dose of VIP should be administered in the doctor’s office. This part of the protocol includes measuring labs (lipase, TGF Beta 1, C4a) right before VIP administration and 15 min after.  Labs should be repeated in 30 days. If there is an elevation in the inflammatory markers after VIP administration, this indicates there is an ongoing exposure to biotoxins. If lipase increases or the patient develops abdominal pain, VIP treatment should be stopped.