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Clinical Studies

Primal Defense Clinical Study Results

Homeostatic soil organisms improve candida, asthma, and other conditions in medically unresponsive chronic disease states. A physician skeptic performs the study…

In January 2000, physician skeptic Paul A. Goldberg, M.P.H., D.C., professor of gastroenterology and public health at Life Chiropractic College, came across promotional materials about a probiotic product called Primal Defense™ containing homeostatic soil organisms thought to be as old as the earth itself; a number of patients had questioned him about this product. Dr. Goldberg is not a big fan of nutritional supplements. He believes the claims surrounding products all too often exaggerate their benefits. He therefore challenged Garden of Life, manufacturer of Primal Defense, to allow him to do his own study utilizing a patient population that had been largely unresponsive to a wide range of medical treatments to see whether this formula could live up to its claims.* The completed study is scheduled to be published this fall in the peer-reviewed journal Progress in Nutrition.

Seventeen patients between 27 to 60 years of age, suffering from chronic diseases unresponsive to standard medical intervention for a minimum of three years, were given eighteen Primal Defense homeostatic soil organism (HSO) caplets per day for 120 days. Patients were evaluated by interview regarding their conditions pre- and post-administration of the Primal Defense caplets along with limited laboratory evaluation. At the termination of the study there were clinical improvements, of varying degrees, in subjects.

Scientific Validation for Primal Defense Soil Organisms
"Sixteen of seventeen subjects completing the study reported improvements in their symptoms including partial to complete relief from bowel problems, decreases in asthmatic symptomatology, increases in energy levels, improvement in skin conditions, improvement in chronic sinus infection and general improvements in overall well being," notes Dr. Goldberg. "No subjects reported any worsening of their symptoms at the completion of the study."

Notable Candida Yeast Reductions
Stool and/or blood testing before and after administration of Primal Defense revealed an appreciable lowering in candida yeast counts in each of the eight subjects who showed elevated yeast counts initially. That is astounding! Every person with elevated candida levels had a significant reduction. No subjects exhibited any significant increase in yeast counts. The results of the before and after stool microbiologies were notable. Based on these samples, the HSOs in Primal Defense appear to be effective at reducing candida yeast growth, Dr. Goldberg notes. Two subjects had candida antibody titers done prior to and after the protocol. Both showed a significant reduction in their titers along with pronounced clinical improvement in their symptoms.

Notable Improvements among Asthmatics
Two subjects had a history of asthma with current symptomatology for which they were on prescription medications. Both of these subjects had a 50 percent or greater reduction in their asthmatic symptoms and in their usage of prescription inhalant medications upon completing the protocol. "Particularly notable was the reduction in asthmatic symptoms seen in two patents who had been asthmatic for many years," notes Dr. Goldberg. "This is consistent with the 'hygiene hypothesis,' which suggests that the upsurge in childhood asthma has accompanied the decrease in bacterial exposure of modern children in industrialized societies and that through greater exposure to bacteria (and other microorganisms) a decrease in the incidence of asthma might be possible."

Notable Improvements in Intestinal Conditions
Eleven of twelve subjects who initially experienced intestinal difficulties reported improvement in their overall bowel function consisting of one or more of the following types: relief from chronic constipation, less irritable bowel-type symptoms, reduced frequency of diarrhea, and greater ease in elimination without straining. None of the subjects reported any negative effects on bowel functioning.

Results Explained
"I have long recognized the importance of the gastrointestinal flora in good intestinal functioning and in regards to a wide variety of systemic health problems," notes Dr. Goldberg. "Dietary modification, fasting, detoxification, lifestyle alterations, all are of positive impact on the gastrointestinal flora when properly applied; yet, with so many forces in our modern lives working against the maintenance of healthy gut flora I felt that additional reinforcement to the flora would be beneficial, particularly in clients with serious chronic health problems."

Dr. Goldberg adds that it has been suggested as far back as the Russian embryologist and immunologist Élie Metchnikoff (1845-1916) that taking supplemental beneficial bacteria to reinforce and balance intestinal flora promotes intestinal well-being and produces systemic benefits. "Mounting epidemiological data and clinical studies support the idea that exposure to a wide variety of bacteria, as found in nature in the soil and general environment, play an important role in the development of healthy immune systems and the general state of resistance, to a wide variety of ailments. Conversely, a theory known as the 'hygiene hypothesis' suggests that many people in modern societies have been too highly protected from normal bacteria. This isolation from the bacteria in our environment, according to the 'hygiene hypothesis,' may contribute to the rise in chronic degenerative diseases such as asthma, inflammatory bowel disease, and a host of allergic conditions.

"It has been suggested that bacteria found in the soil, referred to as homeostatic soil organisms (HSOs) when ingested orally in a probiotic formulation, may have advantages over non HSO-probiotic formulas due to their ability to implant and survive in the gut. The value of HSOs reportedly lies in promoting positive intestinal function with corresponding systemic improvements in the patient's overall nutritional, immunological and gastrointestinal status.

"It has been postulated that human beings ingested HSOs as part and parcel of the dietary intake prior to the sanitizing of food products as it occurs today in most Western nations. There is increasing evidence that our well-intended attempts at sanitizing our homes and food supply with antimicrobial cleaning solutions, disinfectants and soaps may be excessive and contributing to immune systems that do not develop healthy responses to outside influences. This lack of challenge to our immune systems is becoming increasingly suspect in regards to the increasing amounts of asthmatic children, raised under increasingly sanitary conditions, in the United States.

Individual Patient Results
Let's look at the results first, see what kinds of conditions improved (if at all), and to what extent, and then let's try to find the explanation for these results.

Subject 1 A 53-year old male with a 27-year medical history of progressive psoriatic arthritis and ulcerative colitis experienced symptomatic improvement during the first three weeks with improvements in bowel function and arthritic pains followed by an exacerbation with increases in joint inflammation and bloody diarrhea. His Primal Defense dosage was reduced from 18 to two caplets, two times per day, with a reduction of symptoms. The patient increased his dosage over the next several days, returning to 18 caplets per day, completing the 120-day protocol. He reported that his bowel function improved 25 percent by the end of the study with occasional days of "near normal stools," which had not occurred for over five years. Improvements were also noted with less visible blood in his stool, better formed stools, and reduced incidence of cramping. There was no improvement in overall stiffness/joint discomforts. His sedimentation rate fluctuated, but, at the end of the study, remained close to what it had been at the start (55mm/hr). A follow up of the stool microbiology showed a significant reduction in the stool yeast count.

Subject 2 A 42-year-old female radiologist with a five-year history of chronic fungal infection of the lungs also had significant (approximately 25 percent) loss of lung function. She had chronic chest pain upon breathing. Long-term use of the anti-fungal drug Sporonox had not resolved the problem or allowed for any significant improvement. She also had chronic asthma and a significantly elevated serum yeast titer. At completion of the study, the subject reported feeling significant improvement. Her asthma symptomatology had improved by 70 percent, as rated by the subject. She reported greater ease in breathing, improved bowel function, and more energy. She had a reduction in chest pain and significant improvement in spirometer testing by her medical pulmonologist in January 2002. Yeast serum antibody testing performed on this subject at the completion of the study showed a marked drop in the titer from 900 to 438 U/ml. Therefore, it would appear that her infectious state had greatly improved, leading to improved lung function.

Subject 3 A 36-year-old male with chronic psoriasis widespread over his scalp, elbows, face, torso and legs improved with approximately 25 percent of the psoriatic lesions clearing and a lightening of the remaining affected areas.

Subject 4 A 46-year-old male with chronic irritable bowel syndrome since childhood that interfered with social and work activities, reported at the end of the protocol a reduction in symptoms of cramping / diarrhea / irritable bowel of approximately 25 to 30 percent.

Subject 5 A 57-year-old female with chronic diverticulitis, arthritis, and spinal degeneration, did not improve.

Subject 6 A 35-year-old female with chronic constipation of seven years duration and bowel movements that occurred once every three to four days, reported in the third week of the protocol that her constipation had abated entirely with bowel movements occurring every one to two days. She reported an enhanced sense of well being.

Subject 7 A 40-year-old male suffered from chronic fungal sinusitis of six years duration that had been unresponsive to medical treatments including allergy shots, antibiotics, and other drugs. The patient reported excellent response to the 120-day protocol, which was substantiated by examination of sinuses by his physician, an ear, nose and throat specialist. With the improvement of his sinuses, the patient also reported improvement in chronic fatigue that he had suffered from for approximately 10 years.

Subject 8 A 43-year-old female with chronic fatigue, constipation with laxative dependency, and depression, reported significant improvement in energy levels, reduction of depression, and complete relief from chronic constipation of five-plus year's duration with her laxative dependency ended. (Prior to protocol, this patient reported having a bowel movement once every three days. After the protocol, the patient reported a daily bowel movement without laxative usage.)

Subject 9 A 43-year-old female with ulcerative colitis of five years duration, experienced an overall improvement in bowel function (approximately 33 percent as per subject) with reduced bleeding and cramping.

Subject 10 A 34-year-old female with systemic arthritis, joint and muscle pain and irritable bowel syndrome, found that at completion of the protocol she experienced a complete absence of "irritable bowel" symptoms and 75 percent reduction in joint/muscle pain (as per subject's evaluation).

Subject 11 A 22-year-old female was medically diagnosed with rheumatoid arthritis, joint stiffness and general fatigue. She reported 75 percent improvement in joint stiffness and pain along with increased energy levels at completion of protocol. There was a decline in stool yeast growth, accompanied by drop in candida antibody serum titer from 1,688 to 183 u/ml.

Subject 12 A 40-year-old female with chronic diarrhea and fatigue found that after 40 days, her diarrhea completely abated and she experienced increased energy levels. Upon a follow-up examination after 80 days, she continued to report her bowel symptoms and energy improvement remained.

Subject 13 A 33-year-old female with chronic fatigue, indigestion and constipation, said she moved her bowels approximately once every 21 days. After 90 days, she reported that she was now having daily movements, accompanied by resolution of fatigue and digestive issues. A follow-up interview with the subject 30 days later showed she continued to remain well with absence of prior symptoms.

Subject 14 A 55-year-old female who had approximately one third of her colon removed three years earlier due to malignancy, had been experiencing intestinal distress with diarrhea for about three months. Following 60 days, she reported resolution of symptoms. She reported that she continued to remain symptom-free 60 days later.

Subject 15 A 35-year-old female had suffered chronic irritable bowel syndrome accompanied by cramping, diarrhea, and fatigue for over three years. Following 120 days, she reported a 50 to 75 percent symptomatic improvement in all symptoms. A follow-up of stool microbiology showed elimination of yeast in stool.

Subject 16 A 26-year-old male had a history of chronic nausea. Medical analysis/treatment had not been successful in alleviating the problem. Following 45 days, his nausea abated entirely. Upon follow-up 75 days later, his symptoms continued to be absent.

Subject 17 A 29-year-old female had chronic asthma. After 60 days, her asthma symptomatology had improved by 50 percent with a corresponding decrease in her prescription asthma medications.

"Anecdotal evidence suggests that a variety of chronic gastrointestinal, allergic, autoimmune and degenerative conditions can be positively affected by the consistent (three months or longer) administration of an HSO formulation."

Primal Defense


**Statements on this website have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease, but rather are dietary supplements intended solely for nutritional use.

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