CystoProtek^® FAQs

At this time, CystoProtek is not readily available in retail chain pharmacies. However, CystoProtek is available online at www.amazon.com and www.ic-network.com.

To order online from this site, click here or call 1-888-317-0001 and select option 1.

What is CystoProtek?

CystoProtek® is an all natural oral dietary supplement in a soft gel capsule, developed to reduce the symptoms and pain associated with interstitial cystitis¹. The anti-inflammatory properties of glucosamine, quercetin and rutin in CystoProtek’s unique natural formula reduce bladder damage and pain, while its glucosamine sulfate, chondroitin sulfate and hyaluronate sodium help replenish the damaged glycosaminoglycan (GAG) protective layer in the bladder.

Can CystoProtek be taken along with other therapies?

Results of the two clinical studies indicate that CystoProtek can be given to patients who have failed other therapies and can also be given with patients on other oral or intravesical therapies.

Are there known side effects when taking CystoProtek?

In the two clinical studies, there was stomach upset in less than 1% of subjects, especially those with concurrent Irritable Bowel Syndrome. Those who might be more likely to have stomach upset should start taking CystoProtek slowly, beginning with one or two capsules with meals daily and gradually increasing to the full dosage. Placing the capsules in the freezer for approximately 30 minutes before taking them can also help.

Is it safe for children to take CystoProtek for IC?

Yes, with the exception that one should be cautious they do not choke because of the size. It may be prudent to make a pin-hole and squeeze the contents into apple juice, peanut butter, yogurt, etc. (if the child is not allergic) Please keep in mind the the yellowish color is due to the quercetin and can stain clothing.

How did the research and the product come about?

Theoharis Theoharides, Ph.D, M.D, a professor of Pharmacology, Internal Medicine and Biochemistry at Tufts University in Boston, Massachusetts, has been studying the mechanism of allergic reactions and the role of mast cells for approximately 20 years. During this time, he discovered that the mast cell, which tradtionally had thought to only be responsible for allergic reactions, is critically important in inflammation and the pathogenesis of interstitial cystitis and other inflammatory conditions. As a result, he focused on ways he could block the activation of this cell and its secretion of many noxious substances. His work in the field has been published in more than 200 scientific papers, several pieces which are online here.

How are the ingredients in CystoProtek absorbed into the body?

Glucosamine*, Rutin** and Quercetin*** are all bioavailable, meaning they have the ability to be absorbed and used by the body. Chondroitin Sulfate is a large molecule and does not get broken down, but is still absorbed****. Studies have shown that the absorption of Chondroitin Sulfate was significantly enhanced utilizing the liposomal formulation using the olive kernel extract formulation in CystoProtek*#.
It is believed that once these natural substances are absorbed systemically, they are filtered through the kidneys and excreted via the urine into the bladder, where these ingredients produce a local effect. The anti-inflammatory properties of the chondroitin sulfate, quercetin and rutin in CystoProtek’s unique natural formula reduce bladder damage and pain, while its glucosamine sulfate, chondroitin sulfate and hyaluronate sodium help replenish the damaged glycosaminoglycan (GAG) protective layer in the bladder.

In two clinical studies, CystoProtek was demonstrated to be effective in reducing the pain and improving overall symptoms in patients with Interstitial Cystitis (IC)## and was well tolerated by patients ingesting 4-6 soft gel capsules per day for 4-6 months.

What is Chondroitin Sulfate and Sodium Hyaluronate?

Chondroitin Sulfate is one of the main components of cartilage and mucosa layers - including the inner protective layer of the bladder - forming the connective tissue that holds muscles, nerves and blood vessels together. It also inhibits the release of proteolytic enzymes that cause tissue damage. Sodium Hyaluronate is the other main component of these protective connective tissues and is essential in the rebuilding process.

What is Glucosamine Sulfate?

Glucosamine Sulfate is a building block of joint cartilage as well as bladder, prostate and GI protective glycosaminoglycan (GAG) layers. It also has some mild anti-inflammatory properties.

What is Quercetin?

Quercetin a natural non-acidic flavonoid compound extracted from the saphora plant, inhibits mast cells and other inflammatory cells. Quercetin is added to CystoProtek to relieve the pain and discomfort associated with inflammation.

What is Rutin?

Rutin is derived from the saphora plant. In CystoProtek, it adds additional anti-inflammatory qualities.

What is Kernel Olive Extract?

Kernel Olive Extract is a potent anti-oxidant that helps repair damaged tissues. It is also instrumental in helping the body absorb the chondroitin sulfate and rutin, which are made up of large molecules, making it difficult for the body to absorb. Alaven uses only unprocessed kernel olive extract of low acidity from Greece.

Is CystoProtek FDA approved?

CystoProtek is a dietary supplement and does not require FDA approval. However, CystoProtek does have an FDA Certificate. An FDA Certificate of Free Sale means the FDA has certified that all ingredients used in CystoProtek are pure, that all the ingredients and the amount of ingredients used in CystoProtek have been inspected by the FDA to be correct and accurate and that the CystoProtek manufacturer follows "best practices" as defined by the cGMP manufacturing practices. This is great news for all CystoProtek users and those considering purchasing the CystoProtek product. Many times over-the-counter, non-prescription supplements do not have this FDA certification, leaving the consumer to be unsure if the manufacturer is using pure ingredients in the amounts stated. With CystoProtek, the consumer can view this FDA certification and can trust the manufacturing process is pure and with the highest level of product and ingredient integrity. Please feel free to view the certification below.

How does Elmiron work on the bladder, compared to CystoProtek?

Elmiron is a very short (in length) SYNTHETIC (not natural) polysaccharide (multisugar) marketed as able to "replenish" the bladder glycosaminoglycan
(GAG) layer, which is made of very large (100,000 longer) the natural glycosaminoglycans (proteins with sugars attached)
molecules, chondroitin sulfate and sodium hyaluronate.

Cystoprotek delivers both of these natural components and may permit greater absorption due to the fact that they are mixed in natural olive kernel extract, forming simple "liposomes" that are absorbed intact in our intestine. Otherwise, these molecules would be broken down in the gut. The more intact and the bigger the molecules, the more likely they will be able to cover the bladder lining where it has been damaged. Elmiron is too small and gets washed away.

IC bladders have different degrees of inflammation. Even if Elmiron were to help, the ongoing inflammation would degrade Elmiron and continue with the painful cycle. CystoProtek delivers the natural anti-oxidant, anti-inflammatory and mast cell inhibiting flavonoids quercetin and rutin in order to address the inflammation. Moreover, these flavonoids are not water soluble and are not absorbed in a powder form sold by other companies. Once they are mixed with olive kernel extract, their absorption may be increased considerably.
Olive kernel extract has been shown in numerous publications to be cytoprotective and help heal mucosal surfaces, especially in the GI tract.

Is it safe to take CystoProtek® during pregnancy?

CystoProtek® is a dietary supplement. Alaven Pharmaceutical has not conducted and is not aware of any clinical studies which assessed the safety of CystoProtek® during pregnancy or breastfeeding. Therefore, Alaven Pharmaceutical cannot recommend the use of CystoProtek® during pregnancy. Please consult with your physician regarding your options.

Is it okay to take CystoProtek if you are allergic to "Sulfa" drugs? Are the chondroitin and glucosamine "sulfate" ingredients in CystoProtek the same as the sulfa ingredient found in some prescription medications?

There is no relationship between the sulfa group in sulfonamides and the sulphur atom in chondroitin. In addition, there has not been any cross-sensitivity between subjects allergic to sulfa drugs and to sulfated compounds other than sulfa drugs.*
*Absence of Cross-Reactivity between Sulfonamide Antibiotics and Sulfonamide Nonantibiotics - all 9 versions »
BL Strom, R Schinnar, AJ Apter, DJ Margolis, E … - New England Journal of Medicine, 2003 - content.nejm.org

If a person is diabetic, can any ingredients in CystoProtek affect blood sugar levels?

Glucosamine may interfere with insulin sensitivity in diabetics, but only at levels of 1500 mg or higher per day.

Are the chondroitin and glucosomine "sulfate" ingredients in CystoProtek
the same as the sulfa ingredient found in some prescription
medications?

There is no relationship between the sulfa group in sulfonamides and the
sulphur atom in chondroitin. In addition, there has not been any cross-
sensitivity between subjects allergic to sulfa drugs and to sulfated compounds,
other than sulfa drugs.
Strom BL, Schinnar R, Apter AJ, Margolis DJ, Lautenbach E, Hennessy S, Bilker
WB, Pettitt D. Absence of cross-reactivity between sulfonamide antibiotics and sulfonamide nonantibiotics. N Engl J Med. 2003 Oct 23;349(17):1628-35.

* Schwartz and Dorfman. Connective Tissue Research, (1975), Setnikar et al. Arzneimittelforschung. 2001 Sep;51(9):699-725, various publications.

** Boyle et al. Eur J Clin Nutr. 2000 Oct;54(10):774-82, various publications

*** McAnlis et al. Eur J Clin Nutr. 1999 Feb;53(2):92-6, varios publications

**** Murray, Michael T. American Journal of Natural Medicine, 4(4):7, May 1997

*# Theoharides et al., Int J of Immunopathology and Pharmacology 18, 183-88, (2005)

## Theoharides TC, Vakali S, Kempuraj D, Sant R. A retrospective open label study of CYSTOPROTEK® in painful bladder syndrome/interstitial cystitis (PBS/IC). Proeedings NIDDK International Symposium: Frontiers in Painful Bladder Syndrome and Interstitital Cystitis (October 24-27, 2006; Bethesda, MD). Theoharides TC, Sant GR A pilot open label study of CystoProtek in interstitial cystitis. International Journal of Immunopathology and Pharmacology vol. 18: 183-188, 2005

CystoProtek® FAQs

Is CystoProtek® sold in retail pharmacies?