Probiotics and Gastrointestinal Diseases

Transcription

1 Probiotics and Gastrointestinal Diseases Probiotics Promote a Healthy Flora and Should Be Covered for Certain Gastrointestinal Diseases Tag Words: Probiotics, Crohn s Disease, Colitis, VSL # 3 Authors: Michael Gattuso and Julie M. Fagan, Ph.D. Summary: Gastrointestinal Diseases, like Crohn s disease, Ulcerative Colitis and other inflammatory bowel diseases, negatively affect millions of people and have resulted in over 51,000 deaths in 2013 alone. These diseases are currently being treated with powerful prescription strength drugs that contain very harmful side effects to the patient. However, an alternative non-drug treatment, such as taking prescription strength probiotics like VSL#3, has been on the rise. However, these probiotics tend to be somewhat costly, and unfortunately, health insurance companies do not normally cover this effective treatment. We need to change that. Video Link: The Issue: Probiotics Promote a Healthy Flora and Should Be Covered for Certain Gastrointestinal Diseases. Inside our intestinal tract, there are billions of microorganisms that play a pivotal role in maintaining good health. The natural bacteria in our intestines or intestinal flora are essential components of our body s immune system. However, if the flora s been disrupted, it can make the host susceptible to infections, improper bowel movements, and can even trigger genetic diseases such as Crohn s disease, and Ulcerative Colitis. Once these diseases onset, there s no cure, and current pharmaceutical medications only treat the symptoms of the disease, and have harmful side effects that ultimately do more harm to the patient than anything else. However, gastrointestinal specialists and researchers alike have been testing a prescription strength probiotic known as VSL # 3, which has been clinically shown to replenish patient s natural flora, reduce inflammation from infections, and even induce remission in patients with gastrointestinal diseases. Despite clinical evidence that the probiotic can drastically improve a patient s quality of life, they are not normally covered by insurance a company, which needs to change. Disturbance of Flora Can Increase Susceptibility to Infection A Healthy intestinal flora is a necessary component in a host s resistance to infection. The colonization of the intestine by probiotic bacteria prevents pathogenic microorganisms from inhabiting the intestinal tract. For example, the probiotic Lactobacillus acidophilus can bind to cultured human intestinal cell lines and inhibit cell attachment and cell invasion by pathogenic microorganisms (1). Therefore, acidophilus and other probiotic strains inhabited in the intestinal flora are vital components of the body s immune system, and protect us against infections. Therefore, it comes to no surprise that a comprised microbial flora can lead to infections,

2 inflammation, and ultimately, gastrointestinal diseases like Crohn s disease and Ulcerative Colitis (2). Gastrointestinal Diseases Gastrointestinal Diseases have been negatively affecting millions of people s lives for over 90 years. Gastrointestinal Diseases range from Crohn s disease to Ulcerative Colitis. In both instances the body s immune system is comprised and attacks the natural bacteria in one s body causing painful inflammation, diarrhea, and reduces the ability to absorb nutrients. These gastrointestinal diseases are more commonly known as inflammatory bowel diseases. Inflammatory bowel diseases resulted in over 51,000 deaths in 2013 alone, and those with Crohn's disease have a reduced life expectancy (3). A fifth of the individuals with these diseases will be hospitalized each year, and more than 50 % of individuals with irritable bowel diseases, will need to have the disease surgically removed from their body. Inflammatory bowel diseases usually occur in the twenties. However, it can onset at anytime, and all genders are effected equally. These inflammatory bowel diseases can affect any part of the gastrointestinal tract, and there s no cure. Even the countless patients who undergo surgery to remove the disease will ultimately be diagnosed again Treatment options There are a wide variety of pharmaceutical medications available for individuals with these diseases such as corticosteroids like prednisone, live biologic humira, and antibiotics such as flagyl. However, all of these medications only treat the symptoms of these diseases, and have terrible side effects that will reduce the patient s quality of life, and can introduce new diseases that the patient never had before. Prednisone For example, Prednisone been used to treat gastrointestinal diseases since However, like all other medication for gastrointestinal diseases, it only treats the symptoms of the disease, and contains countless adverse side effects that do more harm to the patient s health than anything else. Patients taking the medication will experience anxiety, weight gain, numbness throughout the body, trouble thinking, speaking, walking, breathing, mental depression, diabetes, weakened immune system leading to new infections, loss of bone density and eventually osteoporosis (4). Humira Tumor necrosis factor-alpha (TNFα) is an inflammatory cytokine that usually binds to its own membrane receptor. This complex leads to the inflammation throughout the body, wherever the receptor is present. This is essential, because all gastrointestinal diseases use the patient s own inflammatory cytokines to attack the natural bacteria in one s body. Humira was designed based on the theory that the inflammatory cytokine causing the inflammation in the gastrointestinal disease is TNFα. They designed Humira to bind TNFα, which changes its conformation. It can no longer bind to its receptor, and produce inflammation. However, the body produces other cytokines beside TNFα, and any other one can cause inflammation in a patient with a

3 gastrointestinal disease. In addition, inhibiting TNFα leads to an increased chance of developing a fatal infection such as tuberculosis. Lastly, humira has been linked to the development of lymphoma and 35% of patients take humira developed the fatal cancer (5). Despite these life threatening side effects, Humira remains the number recommended treat options for patients with Ulcerative Colitis and Crohn s Disease. Flagyl Antibiotics have been used to treat bacterial infections since they were discovered in the 1930s. However, a gastrointestinal disease is not a bacterial infection. Flagyl, like other current treatment options, only treat the symptom of the disease, and do not address the underlying issue in gastrointestinal diseases. Since, most gastrointestinal diseases involve the patient s immune system attacking the natural flora, and flagyl works at killing bacteria in the intestines, and they work well when the patient is on them. However, once the patient is taken off antibiotics, the natural bacteria will replenish themselves, and the gastrointestinal disease will re-emerge. In addition, patients with gastrointestinal diseases may be prescribed the antibiotic for years at a time, not for a few weeks like individuals with a minor bacterial infection. This can lead to the development of unpleasant side effects such as headaches, seizures, nausea, and vomiting (6). Lastly, once the antibiotic has been introduced into a patient s system, the body elicits an immune response to it, likely becoming less effective if it s needed again to fight a bacterial infection or for a gastrointestinal disease. Alternative options Many gastrointestinal specialists are shying away from these harmful medications, and looking to the cause of the disease to treat, and to potentially cure gastrointestinal diseases. Gastrointestinal specialists and researchers alike are looking toward prescription strength probiotics since they contain enough colony forming units to inhabit and grow within the intestinal tract, are enteric coated to survive the stomach acid, and have ph indicators that only release the probiotic at the ph of the intestine. Therefore, researchers have been conducting clinical trials with prescription strength probiotics, and the results have shown that prescription strength probiotics provide countless therapeutic effects. What Are Probiotics? Probiotics have been defined in different ways since the term was developed in However, as the definition progressed over the next 40 years, so did the interest in using probiotics to benefit the host. This is evident by the most recent definition by the World Health Organization (WHO), and the Food and Agriculture Organization (FAO) of the United Nations. They define what a probiotic is by stating that probiotic organisms are live microorganisms that when administered in adequate amounts confer a health benefit on the host (7) Health Effects of Probiotics May be Strain-Specific Not all probiotics are created equal. Most probiotics contain some sort of a lactic acid producing bacteria known as lactobacillus. Lactobacillus strains have been used in fermenting food such as

4 yogurt, kefir, cheeses and other dairy products for over 5000 years (8). However, not all lactobacillus strains have the same health benefits. Certain Lactobacillus strains can even cause pneumonia and strep throat. Therefore, strain specific bacteria must be carefully chosen for probiotic supplements. Since different probiotic strains have different health benefits identifying the most beneficial probiotic strains for the host to consume is key. Two of the most commonly used probiotic strains are Lactobacillus Acidophilus and Lactobacillus Rhamnosus GG. However, despite the aforementioned strains being commonly used together, they work quite differently. First, Lactobacillus Acidophilus is used for lactose intolerant individuals. For example, the Journal of Dairy Science conducted a study where lactose intolerant subjects were given milk either inoculated with cells of Lactobacillus acidophilus or un-inoculated regular milk. The study showed that lactose-maldigesting childrens milk inoculated with L. acidophilus or with a yogurt culture were associated with decreased symptoms compared with those with uninoculated milk (9). Moreover, patients who became symptomatic after ingesting the regular milk, showed reduced symptoms once Lactobacillus Acidophilus entered their systems. For example, in the study nine of 10 subjects who were symptomatic following an ingestion of uninoculated milk experienced a reduction in symptoms following ingestion of milk inoculated with L. acidophilus (9). In addition, to Lactobacillus Acidophilus, another prominent Lactobacillus strain has powerful probiotic properties known as Lactobacillus Rhamnosus GG. For example, according to the scientific journal of Applied and Environmental Microbiology, L. rhamnosus GG has perhaps been the most extensively studied probiotic in children and adults. There is strong evidence that when L. rhamnosus GG was given orally at doses greater than 10 9 CFU/day, colonizes the intestine, at least temporarily, and reduces diarrhea (10). Studies such as these have lead to gastrointestinal specialists recommending probiotics to patients with Crohn s disease and ulcerative colitis, so much so that prescription strength probiotics can possibly be prescribed with a note from said specialist to the patient s insurance company. However, it should not take a note from a gastrointestinal specialist begging insurance companies to cover costly prescription strength probiotics that could drastically help improve their patient s daily lives. Over The Counter Probiotics There are thousands of different probiotics available to buy over the counter today. However, most of these probiotics only range from 500 million to 20 billion colony forming units (cfu), and only contain 1-3 different probiotic strains. A colony forming unit in probiotic terms is the amount of colonies that are alive, and viable within the tablet of the probiotic, and are a vital indicator to how effective a probiotic is. For example, the more colony forming units in the supplement, then there s a better chance the probiotic bacteria can out compete the pathogenic bacteria for nutrients, have a better chance of replenishing your natural flora, and can possibly treat gastrointestinal diseases with no side effects. As evident by the chart below, over the counter probiotics are limited in the amount of beneficial probiotic strains they have, and the amount of CFUs they form. Probiotic Supplement Sundown Naturals Acidophilus Colony Forming Number of Probiotic Strains Units 750,000 1

5 Sundown Naturals Probiotic 11 billion 2 Balance Culturelle Gg 10 billion 3 Align Probiotic Supplement 1 billion 1 American Health 500,000 1 Probiotic Acidophilus Natrol Acidophilus 3 billion 1 Nature's Bounty 100 million 1 Acidophilus Nature's Bounty Probiotic GX 20 billion 1 *Probiotic supplements available for over the counter purchase at Shoprite in Spotswood, NJ. Beneficial bacteria in foods Probiotic foods, such as yogurt, sauerkraut, kefir, pickles, kimchi, tempeh, and other fermented food products have been using lactic acid fermentation for thousands of years. These probiotic foods have been sometimes used to provide therapeutic effects for individuals looking to maintain a healthy flora, and can aid with irregular bowel movements. For example, yogurt is the most commonly consumed probiotic food, and usually contains Lactobacillus strains to produce lactic acid in the fermentation process. Although there are other Lactobacilli that can perform lactic acid fermentation, all provide similar therapeutic effects, and can help healthy individuals attempt to maintain a natural flora. Sauerkraut is also considered a probiotic food, and like probiotic supplements, can provide therapeutic effects to individuals with irregular bowel movements, because sauerkraut contains lactic acid bacteria that can line the intestinal tract, and help maintain a healthy flora in healthy individuals. While yogurt does have more variable strains than sauerkraut, it expires much faster, and is less cost effective. Probiotic foods are not considered a treatment for gastrointestinal diseases because it would require consumption of enormous quantities of these foods to equal one prescription strength probiotic. Probiotic foods do not contain enough colony forming units to properly replenish a patient s natural flora (for example: over 6,600 cups of yogurt would be required to be eaten per day to equal one daily dose of VSL#3). Additionally, most of the bacteria in these foods is limited in the variety of strain type (generally only lactic acid bacteria) and won t survive the stomach acid. Clinical Probiotic Trials Treating Gastrointestinal Diseases Thus, current treatment options can be more detrimental than helpful for the patient. Therefore, researchers have been conducting clinical trials with prescription strength probiotics as an alternative treatment option for aforementioned intestinal disorders, and the results have shown that prescription strength probiotics provide countless therapeutic effects. For example, VSL # 3 double strength containing 900 billion CFU and clinical trials have been published by American Journal of Physiology which shows that using DS VSL # 3 can replenish a patient's natural flora, and reduce inflammation from the irritable bowel diseases like Crohn s disease and Ulcerative Colitis in the process (11). For example, a study done in the American Journal of Physiology focused on pretreating rats with VSL double strength # 3 for 1 week before inducing colitis or

6 Crohn s disease. After the rats developed the diseases, the researchers let the disease progress to colorectal cancer. After cancer was induced, the clinical trial showed that none of the probiotictreated animals developed carcinoma, and no high-grade dysplasia was found in either the proximal or mid colon. In contrast, 29% of the animals in the control group developed carcinoma in one or more regions of their colon (12). In addition, there s been numerous scientific clinical studies done by researchers whose papers were published by US National Library of Medicine stating that VSL # 3 double strength has therapeutic effects. First, high-dose probiotics or VSL # 3 can be used for the treatment of active pouchitis in patients with ulcerative colitis. The researchers in the scientific article defined pouchitis as a major long-term complication after ileal-pouch anal anastomosis for ulcerative colitis. In the study, Twenty-three consecutive patients with mild pouchitis were treated with VSL#3, 2 sachets b.i.d. (3,600 billion bacteria/day) for four weeks. Sixteen of 23 patients (69 percent) were in remission after treatment, and all 16 patients who went into remission, maintained remission during maintenance treatment. Only one patient experienced a transient bloating at the beginning of treatment (13). Other than the one patient with bloating, there were no other side effects experienced by patients who took VSL. The study concluded with a definitive statement about using VSL # 3 to treat pouchitis, high doses of the probiotic VSL # 3 are effective in the treatment of mild pouchitis. Further controlled studies are warranted (13). Furthermore, in a different paper published by US National Library of Medicine stated that VSL # 3 can induce remission in children with mild to moderate acute ulcerative colitis. The study used treated eighteen eligible patients between the ages of 3-17 with mild to moderate acute UC received open-label VSL # 3 daily in 2 divided doses for 8 weeks, and the results concluded that treatment of pediatric patients diagnosed with mild to moderate UC with VSL#3 resulted in a remission rate of 56% and a combined remission/response rate of 61% (14). Why most Insurance companies do not Cover Probiotics Most major insurance companies such as Aetna, Cigna, and Horizon Blue Cross Blue Shield do not directly cover probiotic therapy as a prescription, including VSL # 3 Double Strength, despite being a prescription only probiotic. It is not available for prescription, because it s not FDA approved. However, there is no Probiotic on the Market that is FDA approved, and many insurance companies use FDA approval as a preliminary guideline to cover a drug. However, probiotics are not a drug, and that is one of the reasons why they are not FDA approved. Furthermore, in July of 2011 the FDA released it s only statement regarding Probiotic Supplements. The FDA stated the guidelines for what constitutes a probiotic food, and that specific bacterial strains must be alive and active within the food in order to claim a food is a probiotic food. However, the FDA barely mentions probiotics as a supplement, and does not specify any guidelines for what constitutes a probiotic supplement. Supplements sold in nutrition stores are not FDA approved, and unfortunately probiotics are being lumped into the same category as ancient asian herbs and other weight loss supplements. Thus, probiotics are not being looked at for FDA approval and are being unfairly categorized with other supplements in nutrition stores. Community Action: Getting Probiotics Covered by Insurance

7 Thousands of individuals live with moderate to severe Crohn s Disease and Ulcerative Colitis. However, the medications that are prescribed to treat these diseases all have side effects and may or may not be effective in treating these diseases. For example, the current medications that treat inflammatory bowel diseases have side effects that are detrimental to the patient s health, and only treat the symptoms of the disease. Therefore, gastrointestinal specialists and researchers alike have been looking toward alternative treatment options for patients with inflammatory bowel diseases, and both now recommend VSL # 3 as a viable treatment option for patients with inflammatory bowel diseases. VSL # 3 is a prescription strength probiotic that has been clinically tested to replenish a patient s natural flora, induce remission in patients with all types of inflammatory bowel diseases, help patients maintain remission, better digest lactose, and lastly, no patients have had any documented side effects. However, despite being available for prescription only, having successful clinical trials, and being recommended by countless gastrointestinal specialists to treat inflammatory bowel diseases, insurance companies will not cover any of the cost of the prescription. Therefore, most patients do not use VSL # 3 when they develop inflammatory bowel diseases, because they cannot afford it. However, insurance companies have been known to cover a portion or all of the cost of prescription strength VSL # 3 if a patient s gastrointestinal specialist writes a detailed note explaining why the patient desperately needs it to be covered. Gastrointestinal specialists shouldn t have to beg insurance companies to cover a treatment that has been clinically proven to treat inflammatory bowel diseases better than current pharmaceuticals, with no side effects, and that drastically improve their patient s quality of life. Therefore, letters were sent to multiple insurance companies (see below) stating why they should consider covering VSL # 3 for patients with moderate to severe inflammatory bowel diseases. Horizon Blue Cross Blue Shield Cigna Atlantic Ave, Atlantic City, NJ Chestnut St, Cherry Hill, NJ (609) (856) Aetna NJ Family Care 555 Us Highway 1 S # 204, Iselin, NJ Princeton Ave, Trenton, NJ (732) (609) Letter to Insurance Companies Over a year ago, I began developing severe stomach pain. I started drastically losing weight, and I could no longer make regular bowel movements. My physician recommended that I see a gastrointestinal specialist. My specialist saw how my quality of life was rapidly decreasing every day, and he quickly ordered a cat scan to see what was wrong. The scan showed that my intestines were severely inflamed, and that I developed a genetic disease known as Crohn s disease. The very first thing he told me after giving me the diagnosis was that there s no cure. However, there s a wide variety of medications to treat the inflammation caused by the disease. As he spoke his tone became somber. He stated that all of the current treatment options contain side effects that can permanently damage a patient s body. He did not want to prescribe me a

8 powerful corticosteroid like prednisone, or the biologic Humira, because of the detrimental side effects that they have on a patient. Therefore, he treated my inflammation with the antibiotic Flagyl and a mild corticosteroid known as Entocort. I began o feel like myself again, and could even have normal bowel movements. However, when I was taken off the antibiotics, my condition drastically worsened. Despite being on the mild corticosteroid, the inflammation grew larger, and the pain became unbearable. I was given the antibiotic again but my body developed immunity to it and it had no effect. I was hospitalized less than a month later, because the inflammation became so severe that two different parts of my intestines attached to each other. In the hospital I was given a powerful corticosteroid known as Prednisone, and IV antibiotics. I started to feel like myself again. However, I noticed that my bones started to painfully ache. My gastrointestinal specialist stated that Prednisone is associated with a loss of bone density in patients, and they eventually develop osteoporosis. He did not want to keep me on this current medication, so he switched me to Humira. However, he warned me that I would very susceptible to infections, and that 35% of patients on Humira develop lymphoma. He explained that I would have to choose between the lesser of two evils. For a few weeks, I was on both medications, and antibiotics to fight the inflammation of my Crohn s disease. However, the inflammation worsened, and I developed three different infections throughout my intestines, because of my weakened immune system from prednisone, and Humira. I was hospitalized 5 times in less than a year, and required surgery to remove 5 feet of my intestines, because ultimately, none of the current medications worked. They only treat the on the symptoms of the disease, and do not even address an underlying issue of it. I began working with Dr. Fagan at Rutgers University to research alternative treatment options for individuals with inflammatory bowel diseases when we came across VSL # 3. However, researchers have been conducting clinical trials with the prescription strength probiotic as an alternative treatment option for intestinal disorders for years, and the results have shown that the prescription strength probiotic provide countless therapeutic effects. For example, VSL # 3 double strength is probiotic that is available only through prescription and contains over 900 billion CFU. In addition, the American Journal of Physiology has published clinical trials showing that VSL # 3 can replenish a patient's natural flora, and reduce inflammation in irritable bowel diseases. VSL # 3 is now prescribed by gastrointestinal specialists to treat Crohn s disease and Ulcerative Colitis. In one clinical trial, 69 percent of patients were in remission after treatment with VSL # 3, and all patients who went into remission, maintained remission. There were no other side effects experienced by patients who took VSL. In another clinical trial published by US National Library of Medicine, 18 children with mild to moderate acute ulcerative colitis received VSL # 3 twice daily for 8 weeks, and the results concluded that the remission rate of patients with mild to moderate ulcerative colitis was 61%. However, despite being available for prescription only, having successful clinical trials, and being recommended by countless gastrointestinal specialists to treat inflammatory bowel diseases, insurance companies will not cover any of the cost of the prescription. Therefore most patients do not use VSL # 3 when they develop the disease. As an insurance provider that covers pharmaceutical medications that contain life threatening side effects, I strongly urge you to consider covering VSL # 3 for patients with inflammatory bowel diseases. It has been clinical tested to induce remission, help patients maintain remission, and has no side effects whatsoever. Thank you for taking time out of your busy schedule to read this letter, and I hope you have a pleasant day.

9 Sincerely, Michael Gattuso Impact on the Community Unfortunately, none of the above insurance companies have responded to the letters. However, a YouTube video was made to inform individuals dealing with gastrointestinal diseases, on how VSL # 3 could drastically improve their lives, without affecting their wallet. All they d have to do is have their gastrointestinal specialist write a note explaining why VSL # 3 is the best treatment course for their patient, and most insurance companies will oblige to cover some or all of the cost of the prescription strength probiotic. In addition, the video can hopefully introduce VSL # 3 to Gastrointestinal Specialists who are not aware of its therapeutic effects on individuals with irritable bowel diseases. Therefore, this video and paper was developed to inform the public that there s currently a safe treatment option available for individuals with Gastrointestinal Diseases, despite the fact that it s currently being ignored by the FDA, insurance companies, and pharmaceutical corporations alike. References 1. Bernet, M., et al. (1994). LA 1 binds to cultured human intestinal cell lines and inhibits cell attachment and cell invasion by enterovirulent bacteria. Gut. 35(4): Sekirov, I., & Finlay, B. (2009). The role of the intestinal microbiota in enteric infection. J Physiol. 587(17): Naghavi, M., et al. (2013). Global Burden of Disease Study. The Lancet. 386(9963): Drugs.com (2013). Prednisone Side Effects. Retrieved from website: 5. Humira's Official Website, (2013). Safety Considerations. Retrieved from website: 6. Drugs.com, (2015). Flagyl Side Effects. Retrieved from website: 7. Magdalena, A., et al. (2002). Guidelines for the Evaluation of Probiotics in Food. World Health Org. 1(1) eprobiotics.com. What is Lactic Acid Bacteria Lactobacillus? Retrieved from website: 9. Montes, R., et al. (1995). Effect of Milks Inoculated with Lactobacillus acidophilus or a Yogurt Starter Culture in Lactose-Maldigesting Children. J Dairy Sci. 78(8): Gregor R. (1999). The Scientific Basis for Probiotic Strains of Lactobacillus. Appl. Environ. Microbiol. 65(9):

10 11. Uronis, J., et al. (2011). Gut Microbial Diversity is Reduced by the Probiotic VSL # 3 & Correlates with Decreased Colitis. Inflamm Bowel Dis. 17(1): Appleyard, C., et al.(2011). Pretreatment with the probiotic VSL#3 delays transition from inflammation to Colitis. Am. J. Phys. 301(6): Gionchetti P., et al. (2007). High-dose probiotics for the treatment of active pouchitis. Dis. Colon & Rectum. 50(12): Huynh HQ., et al. (2009). VSL#3 induces remission in children with mild to moderate acute ulcerative colitis. Inflamm Bowel Dis. 15(5):

11 Appendix: Drug Insert for VSL#3 Double Strength

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13 Letter to the Editor The following letter was sent to AARP the Magazine via the address Please consider the following personal statement to be published in your magazine. Thank you, Michael Gattuso Probiotics to Treat GI Disorders I wanted to share with your readership my experience with alternative non-drug but doctor prescribed treatment options for individuals with inflammatory bowel diseases. Initially, I was prescribed Prednisone, Humira and then Flagyl but these pharmaceuticals only treat the symptoms of the disease and come with some potentially harmful side effects. I learned that 35% of patients who take Humira develop lymphoma, and patients who take Prednisone long term can develop diabetes and osteoporosis. I have heard that probiotics promote GI health and asked my doctor whether probiotics would help me. He said the only one that is worth considering is the probiotic VSL#3. I went to the pharmacy and couldn t find it on the shelves, because it needs to be kept refrigerated, and you need to ask the pharmacist for it. I was about to purchase it and stopped because it was over my budget ($75). There is a double strength formulation of VSL#3 (DL) that requires a prescription so I thought I could use my prescription plan to pay for it (>$150), but insurance companies do not cover prescription strength probiotics, because probiotics are not drugs, and therefore, not FDA approved. However, I approached my gastrointestinal specialist about using VSL#3(DS) and he stated that it can be covered by insurance companies, if a physician wrote a detailed letter to an insurance company stating why their patient needed it. Therefore, if you re currently suffering from a gastrointestinal disorder, I strongly urge you to contact your gastroenterologist, and see if you can get the treatment covered by your insurance company. The prescription strength probiotics contain enough beneficial bacteria to inhabit and grow within the intestinal tract, they re enteric coated to survive the stomach acid, have ph indicators that only release the probiotic at the ph of the intestine, and can/are used to treat gastrointestinal diseases. Just to compare, you d have to eat > 6,600 yogurts per day to equal the daily dose of VSL#3. In published clinical trials, VSL#3 has replenished an individual s natural flora, was able to induce remission, helped individuals stay in remission, and individuals experienced no side effects when taking the prescription strength probiotic. I hope that some of AARP s readership will benefit from this information on the use of prescription strength probiotics to treat GI disorders like irritable bowel syndrome.