The Effects of Combination Therapy Utilizing Calcium Disodium EDTA Suppositories and Tetracycline for the Treatment of Prostatitis and Prostate Calcification

Preparation

Detailed information of the extended prostate study is on www.prostate90study.com. If you choose to be in the study, follow the instructions and links to the three questionnaires listed below and complete the information requested. You have the option of selecting a more simplified to comprehensive protocol:

PROCEDURES:

One thousand volunteers, ages 40 and older, will participate in this study. All participants are required to be on the treatment program of Detoxamin suppositories, one every other day, tetracycline daily, vitamin/mineral supplements daily and probiotics daily for the three month study period.

In regard to diagnostic procedures, the study is divided into three groups:

If you decide to participate in this three-month study, you must sign the informed consent and click "submit", you will receive further instructions via email directing you to the Medical Intake Form. Fill out the Medical Intake form. After you fill out this form, click submit. Your medical history will be sent to the research staff, who will review it and decide if you qualify to be placed in the study. You will receive an email regarding your acceptance or notice of non qualification shortly after the review process. You will then be instructed to select one of the above test groups (I. - III) and to place an order for your selection. All participants will receive a treatment package consisting of:

1. Detoxamin suppositories to be inserted one every other day prior to bedtime
2. Health Genesis multi vitamin/mineral tablets, taken orally - 3 tabs at breakfast and 3 tabs at lunchtime each and every day.
3. Biotic Detox Support (probiotics) to be taken orally one per day each and every day
4. Tetracycline 500mg capsules - one cap to be taken orally each and every day

If you choose to participate in only the treatment program without diagnostics, (1.), you may purchase the Detoxamin suppositories, Biotic Detox Support, Health Genesis vitamins and tetracycline, see costs below. You must fill out the Day 1 and Day 90 questionnaires to ascertain the effects of the test materials on your quality of life.

If you choose to get a fecal heavy metal test, you will be sent the Doctors Data mail package along with your treatment products. First provide a fecal sample according to the instructions within the package and mail it in the provided carton. Next, fill out the on-line Day 1 questionnaires. Then begin the treatment protocol as described below. At the end of the 90-Day study period, fill out the questionnaires and send in the final fecal sample. Detoxamin may remove some minerals from the body, so you will be instructed to take a three-month supply of a multiple vitamin/mineral supplement, called Health Genesis, on a daily basis. You will also be required to take a three-month supply of Biotic Detox Support probiotic oil matrix capsules to replenish the good bacteria in your digestive tract (intestines) on a daily basis.

If you choose the sonogram and fecal heavy metal evaluations - before and after treatment (3.), you must first schedule an appointment at Tustin Longevity Center for the sonogram. There, you will meet Dr. Brett Jacques for a digital rectal exam (DRE) and then be scanned with the ultrasound by a highly qualified technologist in a private examination room. Afterwards, you will receive the treatment package including the fecal heavy metal test kits with complete instructions for filling out the Day 1 questionnaires, the International Prostate Scoring Survey form, the NIH Prostatitis Index Scoring form and the Erectile Function form. Then the next day, mail in your fecal sample, fill out the questionnaires and then start taking the treatment products. At the end of the 90-Day study period, schedule an appointment at Tustin Longevity Center for your second sonogram, send in the final fecal sample and fill out the three questionnaires. For sonogram scheduling, please contact Tustin Longevity Center: 714-544-1521 between 9:00 AM to 5:00 PM, Monday through Friday, Pacific Time.

DETAILED SUPPOSITORY INSTRUCTIONS:

Detoxamin EDTA suppositories are solid, bullet-shaped preparations designed for easy insertion into the anus (rectal passage). Detoxamin is manufactured in a cocoa-butter base, a time-release agent (natural fatty acid base), and 750 mg of Calcium-Disodium EDTA. Detoxamin will dissolve at body temperature and will gradually spread over the lining of the lower bowel (rectum), where it is absorbed into the bloodstream. Detoxamin is designed to release 750 mg of Calcium Disodium EDTA slowly, throughout the evening.

(Follow this protocol over the three-month period)

I.	Eat early in the evening, about three to four hours prior to bedtime and before inserting Detoxamin suppository.
II.	Detoxamin instructions: Prior to bedtime, empty your bowels, if possible, before you insert Detoxamin. Wash your hands. Remove the plastic wrapping from the Detoxamin suppository. Either squat or lie on your side with one leg bent and the other out straight. Gently, but firmly, push the suppository into the rectum: FLAT end first until past the sphincter muscle (opening of the rectum). By inserting the flat end opposed to the pointed end, the suppository will travel higher up the rectum more easily. If necessary, moisten the suppository with a little water. Push it in far enough so it doesn't slip out. Close your legs and sit or lie still for a few minutes. Wash your hands again. Try not to empty your bowels for at least 80 minutes. Try to consume 2-3 large glasses of purified water per day. In addition, the protocol requires you to use following daily:
I.	Take the supplied Health Genesis multi-vitamins (three tablets at breakfast and three tablets around lunchtime -- six tablets per day).
II.	Take two capsules of Biotic Detox Support probiotics in the morning every day.
III.	Each evening take the 500mg capsule of tetracycline orally with a glass of water.

At the end of the study - Day 90

1. You will receive emails near and on the final day with links reminding you to fill out the three questionnaires. Please complete them on that day on this site, (Day 90)
2. If you choose to get the Drs. Data heavy metal test, mail in you second and final fecal sample and fill out the 90-day questionnaires.
3. If you chose to get the sonogram and the Drs. Data heavy metal test, you must schedule second and final sonogram at Tustin Longevity Center (see below), mail in fecal heavy metal test in the enclosed sample package and then complete the online questionnaires.

Crucial Dietary Restrictions

The following are to be STRICTLY AVOIDED FOR AT LEAST 7 DAYS PRIOR TO THE BASELINE BLOOD AND STOOL SPECIMEN COLLECTIONS AND THROUGHOUT THE DURATION OF THE STUDY: bentonite clay, Na-alginate, keratin, aluminum-containing antacids, colonics, barium enemas, mineral or castor oil, colloidal minerals, activated charcoal, "chitosan-type" products, chlorella, cilantro, porphra-zyme or other chlorophyll-rich supplements/phytonutrients, products that contain EDTA or any other potential metal mobilization agent. Due to the potential lead contamination of some calcium supplements, calcium supplementation should be withheld unless absolutely necessary. Calcium is included in the vitamins that are supplied. Refrain from excessive exposure to sunlight while taking the tetracycline.

In case of emergency only, call 911 for immediate treatment or you can reach Dr. Ellithorpe's office between the hours of 8:00 AM and 5:00 PM Pacific Standard Time.

It is extremely IMPORTANT that you do not have allergies to tetracycline. If you do, you will not be permitted to be in this study.

Cost of supplies and protocol

The treatment requires the purchase of a ninety-day supply of the following four products. The package is specially discounted for this study at a cost of $575 (price includes shipping).

• Detoxamin Suppositories (three month-supply 45 suppositories)
• Health Genesis vitamin minerals ( three bottles of 180-count tablets)
• Biotic Detox Support (two bottles of (probiotics 60 capsules)
• Tetracycline (three-month supply of ninety 500 mg capsules; prescription included)

Choose one of the following protocols (listed at special study discounted pricing)

• Before and after, fecal heavy metal tests from Doctor's Data Labs ($100 ea) plus the treatment package ($575) for a total of $775
• Both the 2 Sonograms ($500 ea) & the 2 Doctor's Data fecal heavy metal tests ($100 ea) plus the treatment package ($575) for a total of $1775 (Only the Sonograms will be billed through Tustin Longevity Center, all other items will be billed through World Health Products)
• If you choose not to participate in the diagnostic tests (fecal and sonograms), then you may purchase Detoxamin, Health Genesis and Biotic Detox, without tetracycline at www.prostate90.com