* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
MicroLactin
Frequently Asked Questions
What does MicroLactin� do?
MicroLactin� is a revolutionary new dietary supplement clinically proven to promote healthy joint function. This unique product has been shown in published clinical trials to significantly decrease temporary joint pain and stiffness and significantly improve mobility and range of motion. It is well tolerated and easy to take.
What are the active ingredients in MicroLactin�?
The active ingredients in MicroLactin� are concentrated milk proteins. These proteins are found naturally in cow's milk and are comprised of unique antibodies and other bioactive micronutrients. Using a patented process that isolates and concentrates these natural proteins in sufficient quantities, MicroLactin� can be encapsulated.
How does MicroLactin� work?
MicroLactin� works by making the "tight junctions" of the blood vessels even tighter. This in turn significantly reduces the emigration of neutrophils to the site of inflammation (i.e. sore joints). As a result, the cycle of inflammation and pain is broken resulting in better feeling joints, increased flexibility and quicker joint recovery.
What is the recommended dose of MicroLactin�?
Clinical studies support using a loading dose of two (2) grams twice daily for the first 7-10 days followed by a maintenance dose of one (1) gram twice daily thereafter.
Do I need to take MicroLactin� every day?
Yes, a continuous daily supply of the concentrated micro-proteins found in MicroLactin� is necessary to maintain its positive effects.
Should I take MicroLactin� before or after a meal?
For maximum benefit, MicroLactin� should be taken twice daily-once in the morning and once in the evening. You may take it with or without food.
When will I start to feel the benefits of MicroLactin�?
In the MicroLactin� clinical trials, participants experienced significant improvement in joint health in just 1-2 weeks. Many users report benefits in the first few days of use.
What age do you have to be to take MicroLactin�?
To Date, MicroLactin� has only been clinically tested in adults. Use by individuals under the age of 20 should be done under the care of a health care provider.
What clinical work has been done with MicroLactin�?
Two clinical trials have been completed and published evaluating the efficacy and safety of MicroLactin�. In each of these studies, MicroLactin� was found to deliver significant relief of joint pain, joint stiffness and improve mobility in patients with osteoarthritis. Nine out of ten patients who were assigned to the MicroLactin� group had significant relief of joint symptoms. It was also found to have a 60% greater treatment effect than glucosamine for overall improvement in joint function.
Does MicroLactin� have any side effects?
No. In clinical studies, no reports of serious adverse events were recorded. Also, Humanetics has not received reports of side effects by consumers who have used the product since its commercial launch in 2001.
Are there any health conditions or medications that interact with MicroLactin�?
Only 2 to 5% of the population have an allergy to cow's milk protein. Those individuals should avoid taking MicroLactin�. In addition, milk proteins in MicroLactin� may interfere with the activity of tetracycline-type antibiotics. Please consult your physician.
Can I still use MicroLactin� if I'm lactose intolerant?
Yes. MicroLactin� is 90% lactose free.
Can MicroLactin� be taken with other joint health products?
Yes, MicroLactin� can be taken with any other joint health product. Please consult your physician if you are taking any prescription medications.
Couldn't I just drink regular cow's milk and get the same effect?
The bioactive ingredients found in MicroLactin� are also found in regular cow's milk but in concentrations that are much too low to be practical. In addition, MicroLactin� is derived from milk that is obtained from specially treated and cared for cows in New Zealand. This milk then undergoes a patented isolation and concentration process to give you the most beneficial active ingredients in a convenient capsule form.
How long has MicroLactin� been around?
The technology to create MicroLactin� was discovered in the late 1950's. Over the past 40 years this technology has been further refined to the high level it is today. The first commercial sale of MicroLactin� started in 2001.
Does MicroLactin� have any benefits other than joint care?
Yes. Interestingly, there have published clinical trials illustrating the benefit of the active ingredients in MicroLactin� in maintaining blood pressure and healthy cholesterol levels. There are potential benefits in sports recovery that is supported by a clinical trial showing improved recovery times in long distance runners. Finally, MicroLactin� is also rich in antibodies, which may play a role in promoting good intestinal health
The Technology Behind Milk Micronutrients
Milk is a complex substance consisting of fat (cream), casein (protein from which cheese is made), whey proteins (which include IgG antibodies), milk sugars, vitamins, and minerals. Milk has traditionally been viewed only from a nutritional standpoint. We all know that the macronutrients in milk (calcium, vitamins, proteins, etc.) can benefit our health. However, SMBI's research has identified that milk also contains micronutrients that have unique and useful biological activity. However, this activity occurs at a very low level in normally processed milk.
Over the past 30 years SMBI researchers have discovered that stimulation of a cow's immune system can enhance the expression of the many biologically useful micronutrients that naturally occur in milk. This work is built upon the theories and work of Dr. William Petersen, Professor of Dairy Science at the University of Minnesota. It was Dr. Petersen who pioneered the concept of "immune milk" in the 1950's. Petersen confirmed the health benefits of milk from cows treated with special immune stimulants. Petersen demonstrated that the cow's natural process of creating antibodies to the antigens present in the immune stimulant was passed to the milk and could benefit anyone who consumed the milk. It was SMBI that put forth the money, effort and scientific methods necessary to understand the "how and why" of this phenomenon. SMBI has spent years determining both how to enhance the expression of the micronutrients in milk and which fractions of milk contain the micronutrients. Furthermore, SMBI has developed commercial-scale processes to separate and manufacture the micronutrients.
SMBI's research has led to the development of a potent fraction of milk called MicroLactin�. This fraction contains the same biological activity of intact milk at a much lower dose. It is anticipated that even further breakthroughs will be made and even more potent, bioactive fractions will soon be made available to consumers.
8,000 Case Histories Reveal the Power of Milk Micronutrients
Continuously, from 1960 to 1996, SMBI distributed, free of charge, a powdered drink containing milk micronutrients to consumers around its headquarters in Cincinnati, Ohio. Consumers were asked to complete and return survey forms to the company. This 35 year study, which documented over 8,000 case histories, has become known as the Ohio Survey.
The Ohio Survey is a landmark study of the safety and efficacy of SMBI's milk micronutrients. We know of no other dietary supplement with such extensive documentation of use and effects. The intent of the Survey was to gather a large database of consumer usage to understand both the safety and benefits of daily consumption of the milk micronutrients. Data gathered from participants included basic background information on sex, age, weight, height, doctor's or subject's assessment of health status including any known ailments, and a general health history with documentation of any medications. Participants were asked to consume 45 grams of powder containing the special milk micronutrients which was typically reconstituted with water and consumed once daily as a beverage. Participants were asked to periodically complete survey forms to document their health status and any side effects.
During the first fifteen years of the survey the company documented 3,545 case histories. The results showed that the product was well tolerated and, more importantly, that the users perceived significant health benefits. In the early 1990's SMBI computerized the database and during the last five years of the Survey, documented another 4,867 consumer experiences with the supplement. The accompanying table shows the total number of participants, their reported conditions at the beginning of the survey and the percentage that reported improvement. As can be seen by the data, 73.5% of all consumers reported an improvement in their overall health.
SMBI used the results of the Ohio Survey to steer its clinical research efforts. Since the Survey was not a controlled clinical trial, the company took the further step of conducting a multitude of controlled clinical trials. These human trials, conducted by independent research organizations under controlled circumstances, confirmed many of the findings in the Ohio Survey.
OHIO SURVEY RESULTS 1992-1996
| Condition
|
Total Participants
|
Percent Reporting Improvements
|
| All Conditions
|
4,867
|
73.5%
|
| Joint Pain
|
2,737
|
83.7%
|
| Cholesterol
|
1,123
|
71.5%
|
| Blood Pressure
|
714
|
66.4%
|
| Fatigue
|
803
|
74.2%
|
| Sleep Problems
|
525
|
69.3%
|
| Indigestion
|
287
|
70.7%
|
| Allergies
|
379
|
67.8%
|
| Lung Conditions
|
169
|
59.2%
|
| Skin Conditions
|
209
|
54.1%
|
Overwhelming Clinical Evidence Supports Product Claims
In an effort to validate the dramatic findings of the Ohio Survey, SMBI scientists designed and conducted a multitude of clinical trials in various health areas. Since 1975, the company has completed 16 well-controlled trials. These studies were all conducted by independent clinical research organization or at major research universities. In total, over 700 subjects have been studied and documented.
This research supported the findings of the Ohio Survey. The strength and validity of the results in these clinical trials have supported the issue of more than 200 worldwide patents on the uses of SMBI's micronutrient technology.
Summary of Clinical Activity
| SMBI Product
|
Indication
|
# Patients
|
Date
|
Duration
|
| Stolle
|
Rheumatoid Arthritis
|
20
|
1975
|
24 weeks
|
| Milk
|
Juvenile Arthritis
|
10
|
1992
|
24 weeks
|
| Powder (8-100)
|
Rheumatoid Arthritis
|
211
|
1993
|
24 weeks
|
| Powder (8-100)
|
Osteoarthritis
|
34
|
1992
|
6 weeks
|
| Powder (8-100)
|
Cholesterol
|
20
|
1985
|
6 weeks
|
| Powder (8-100)
|
Cholesterol
|
11
|
1989
|
8 weeks
|
| Powder (8-100)
|
Cholesterol
|
30
|
1992
|
10 weeks
|
| Powder (8-100)
|
Cholesterol
|
167
|
1994
|
|
| Powder (8-100)
|
Hypertension
|
27
|
1993
|
2 weeks
|
| Powder (8-100)
|
Runners
|
20
|
1993
|
24 weeks
|
| Stolle
|
Cholesterol
|
19
|
1993
|
12 weeks
|
| Milk plus
|
Hypertension
|
30
|
1994
|
12 weeks
|
| WPC (S-200)
|
Psoriasis
|
9
|
1993
|
12 weeks
|
| Milk plus
|
Psoriasis
|
49
|
1994
|
12 weeks
|
| Permeate (S-300)
|
Ragweed
|
65
|
1993
|
6 weeks
|
| Stolle WPC
|
Cholesterol
|
29
|
1993
|
12 weeks
|
Clinical Totals: 751 Patients
Clinical Trial In Highly Trained Runners Confirms Benefits
In 1993 SMBI sponsored a clinical trial at the University of Puget Sound in Tacoma, Washington to determine the effectiveness of its milk micronutrients in the performance of highly trained distance runners. The study was randomized, double-blind and placebo controlled with a duration of six months. At the end of the six-month trial 7 of 10 runners who had been consuming the milk micronutrients reported overall improvement versus only 2 of the 8 runners on the placebo.
The following specific results were documented from the runners who consumed the milk micronutrients during the trial:
- Highly significant perceived improvement in training
- Improved 5 kilometer race times
- Faster recover time between training sessions
- Significantly shortened creatine kinase (CK) recovery times
- Slight but significant decrease in percent body fat
The study director included the following remarks in her discussion of the trial, "These results support the hypothesis that [milk micronutrients]�will enhance a runners performance. Even though this study was designed using highly trained, non-seasonal runners, [SMBI's milk micronutrients] might be expected to enhance performance in less dedicated athletes in a variety of sports."
Manufactured in New Zealand From Hormone Free Milk
SMBI milk micronutrients are an all-natural dairy product from grass-fed cows and contain no additives. SMBI products are manufactured in New Zealand, where milk production is carefully managed according to very strict quality and herd management standards set by the New Zealand Dairy Board, which strictly prohibits the use of Bovine Growth Hormone (BGH).
The Effects of Milk Protein Concentrate on the Symptoms of Osteoarthritis in Adults: An Exploratory, Randomized, Double-Blind, Placebo-Controlled Trial
John L Zenk, MD, Tami R Helmer, MD, and Michael A Kuskowski, PhD
ABSTRACT
Background: Reconstituted hyperimmune milk product has been shown to have anti-inflammatory qualities, prompting further research into its use for the relief of osteoarthritis symptoms. A concentrated form of this milk product, milk protein concentrate (MPC), contains the high-molecular-weight and low-molecular-weight components present in the reconstituted milk product.
Objective: The purpose of this exploratory study was to assess the effects of MPC on the symptoms of osteoarthritis in adults.
Methods: Patients aged > 19 years with physician-diagnosed osteoarthritis with daily joint pain, stiffness, and immobility were eligible. This was a prospective, randomized, double-blind, placebo-controlled trial lasting 6 weeks and having 3 treatment arms: MPC 2000 mg BID, glucosamine sulfate 500 mg TID, and placebo. Osteoarthritis symptoms were assessed using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Results: Forty-two participants were enrolled (8 men, 34 women; mean age, 59 years [range, 34-86 years]); 35 patients (5 men, 30 women) completed the study. Due to significant baseline differences in 3 (stiffness, acitivities, and total) of the 4 (pain, stiffness, activities, and total) WOMAC Osteoarthritis Index scores in the placebo group compared with the MPC- and glucosamine sulfate-treated groups (P < 0.05), the results of this study were restricted to the analysis of intragroup performance from baseline to the completion of the study. The results showed significant improvement from baseline to week 6 for the MPC-treated group for all 4 scores (P < 0.005). In the glucosamine sulfate-treated group, a significant improvement was found in stiffness and total WOMAC Osteoarthritis Index scores from baseline to week 6 (P < 0.05 for both) but not in the pain or activities scores. In the placebo group, no significant changes were found in any of the WOMAC Osteoarthritis Index scores.
Conclusion: The results of this study indicate that MPC, when givien at a dose of 2000 mg BID, was effective in relieving the symptoms of osteoarthritis, including joint pain, joint stiffness, and immobility, in this patient population.
Abstract posted with permission of the publisher from Zenk, et al, Current Therapeutic Research Vol. 63(7), and pp 430-442, Copyright 2002 by Excerpta Medica, Inc.
Cholesterol-Lowering Effect of Skim Milk from Immunized Cows in Hypercholesterolemic Patients
Alain Golay, Jean-Marc Ferrara, Jean-Pierre Felber, and Heinz Schneider
The effect of skim milk from cows immunized against a variety of human intestinal bacteria on serum cholesterol concentrations was examined in 11 patients with primary hypercholesterolemia in a 24 week, randomized, double-blind, placebo-controlled, crossover study. After a 4 week baseline period patients were treated for eight weeks either with skim milk from immunized cows (active) or with control skim milk (placebo) followed by an 8 week period with the treatment order reversed. Eight weeks of active treatment with skim milk from immunized cows reduced serum total cholesterol concentrations by 0.52-0.59 mmol/L (mean-SD: P<0.025), or 8%, LDL cholesterol by 0.16-0.59 mmol/L (NS), or 4% and the atherogenic index (total cholesterol/HDL cholesterol) by 0.42-1.85 (P<0.05), or 8%, compared with the placebo treatment. Reversal of the favorable development occurred upon cessation of active treatment. We conclude that daily supplementation of a normal diet with skim milk from immunized cows can result in a significant reduction of elevated blood cholesterol concentrations.
Am J Clin Nutr,1990;52:1014-9.
Cholesterol-Lowering and Blood Pressure Effects of Immune Milk
Susan J Sharpe, Gregory D Gumble, and D Norman Sharpe
The plasma cholesterol-lowering and blood pressure effects of a skim milk powder (immune milk) produced from diary cows hyperimmunized with a multivalent bacterial vaccine were assessed in a double-blind crossover study of hypercholesterolemic subjects who consumed daily 90 g immune milk or a normal product. There was a significant reduction in plasma total and LDL cholesterol of 5.2% (95% CI 2.5, 7.9) and 7.4% (95% CI 4.1, 10.7), respectively, with 10 weeks of immune consumption compared with control, but no change in HDL cholesterol or triglycerides. A significant systolic and diastolic blood pressure-lowering effect (5 and 4 mm Hg, respectively) was also demonstrated. Thus, immune milk may be a useful adjunct in the dietary management of hypercholesterolemia and the mechanisms of its cholesterol-lowering and blood pressure effects warrant further study.
Am J Clin Nutr 1994;59:929-34.
Effect of Immune Bovine Milk of Streptococcus Mutans in Human Dental Plaque
The use of a mouthrinse bovine milk containing antibodies to Streptococcus mutans resulted in an initial reduction in the numbers of recoverable Strep. mutans in a group of 9 individuals. Ten volunteers who used control bovine milk that contained no antibody activity to Strep. mutans had variable levels of plaque Strep. mutans. In addition, after culture on Mitis Salvarius and Gold's agar, the plaque Strep. mutans from subjects who used the immune bovine milk rinse formed smaller colonies than those from pre-treatment plaque samples of subjects who used the control rinse.
Archs Oral Biol. Vol. 36, No. 1 pp. 41-47, 1991.
Effects of Stolle Milk in Patients with Rheumatoid Arthritis: Double Blind, Placebo-controlled, Crossover Study
This was a double-blind crossover study in 20 patients with confirmed rheumatoid conducted by Dr. William Niedermeier, Department of Rheumatology, University of Alabama at Birmingham, AL; 1976. Patients received either Stolle milk or the placebo during the first 6-month period. At the end of this time, those that were receiving Stolle milk were placed on the placebo and those that were receiving placebo were placed on Stolle milk for the second 6-month period. At no time did the patients know whether they were receiving Stolle milk or placebo. Efficacy evaluation was based on standardized parameters.
Both milk products were well tolerated by all patients. At the end of the second 6-month period, 11 patients volunteered to remain on the study for an additional 6 months. A favorable response to Stolle milk was obtained for all clinical parameters. During the periods in which the patients were taking Stolle milk the duration of morning stiffness, severity of joint pain, and type and quantity of drugs used were reduced, and the ability of patients to conduct normal activities improved.
A Multicenter, Double-blind, Placebo-controlled Study of Stolle Milk as Adjunct Therapy in Adult Rheumatoid Arthritis
Investigators included fourteen board-certified rheumatologists throughout U.S.A. The study was designed, monitored, and reported by Pharmaco, an Independent clinical research organization based in Austin, Texas; 1993
The study was designed to evaluate the safety and efficacy of Stolle milk powder compared with commercial (placebo) milk powder in 211 patients with adult rheumatoid arthritis. The dosage was 45 grams Stolle or control milk powder twice daily. Evaluation criteria included assessment of overall disease severity, joint counts, disability monitoring, duration of morning stiffness, consumption of arthritis medication, laboratory tests, and visual analog pain assessments.
Marked improvement was detected in Stolle milk patients with regard to joint counts, duration of morning stiffness, and visual analog pain scores.
Regarding side effects, no difference between Stolle milk and placebo groups and no clinically significant changes in laboratory test results or physical examinations were detected.
A Study of the Efficacy and Safety of Stolle Milk (S200) in the Treatment of Mild to Moderate Essential Hypertension
This study was conducted independently by Hsiang-Tai Chou, MD, Division of Cardiology, China Medical College, Taichung, Taiwan, R.O.C., 1994, to evaluate the blood pressure-lowering effects and safety of Stolle milk blended with Stolle whey protein concentrate (S-200) in 30 patients with mild to moderate essential hypertension. The study consisted of a run-in phase of 2 weeks during which time all patients took control, nonfat dry milk powder, and a randomized-treatment phase of 12 weeks during which time 10 patients continued to take control milk and 20 patients took S-200 milk powder. The dosage was 32.5 g Stolle (S-200) or control milk powder twice daily. Blood pressure was monitored before and during treatment, and blood samples were collected for clinical laboratory evaluation.
In both treatment and control groups blood pressure decreased significantly during the 12-week treatment phase. The decrease in the S-200 group was statistically greater than in the control group and was clinically relevant.
Double-blind Controlled Trial on the Effect of Stolle Milk on Recovery After Exercise in Highly Trained Runners
This study was conducted at the University of Puget Sound, Tacoma, WA, 1993 to determine the efficacy of Stolle milk powder as an ergogenic aid to performance in runners. Twenty highly trained, non -seasonal, distance runners who had been consistently running for three or more years were recruited. After a 4-week baseline period during which all runners consumed 45 grams of placebo nonfat dry milk reconstituted in water twice daily, runners were randomized into a Stolle milk and a control group, on a double-blind basis, and followed for 6 months.
Both Stolle milk and control milk were well tolerated. Side effects related to milk consumption were negligible. The following apparent benefits were detected in the runners consuming Stolle milk:
- Highly significant runner perceived improvement in training
- Improved 5 kilometer race times
- Faster recovery time between training sessions
- Significantly shortened creatine kinase (CK) recovery times
- Slight but significant decrease in % body fat despite a slight increase in body weight
Milk Micronutrients: Unique Technology Merits More Than 200 Worldwide Patents
SMBI's extensive dedicated research and unique technology have resulted in more than 200 U.S. and foreign patents and patent applications covering a wide range of specific health benefits of these innovative milk micronutrients. The patents are based on SMBI's proprietary technology to develop and extract nutritional products and ingredients from specially processed cow's milk. Each patent is based on carefully controlled scientific studies backed by substantial clinical trials.
Summary of SMBI Patents and Patent Applications for Products/Ingredients for Human Use
- Anti-Inflammatory Factor (AIF), Method of Isolation & Use
- Method for Treating Disorders of the Vascular and Pulmonary Systems
- Prevention and Treatment of Rheumatoid Arthritis
- Antihypertensive, Hyperimmune Milk, Production, Composition, and Use
- Method of Treating Protozoal Gastrointestinal Disorders By Administering Hyperimmune Milk Product
- Immune Suppressive Product
- The Use of Hyperimmune Milk to Increase Longevity
- The Use of Hyperimmune Milk to Prevent Suppression of T-Lymphocyte Function
- Passive Immunization
- Deodorant Containing Bacterial Antibodies
Patents for MicroLactin
U.S. Patent Number: 4,879,110
Inventors: Lee R. Beck; Ralph J. Stolle, Lebanon, Ohio
Date of Patent: November 7, 1989
Anti-hypertensive Hyperimmune Milk, Production, Composition and Use
ABSTRACT: The invention relates to a method for inducing the production of milk anti-hypertensive factor in an animal, to a method for the isolation of said factor from the milk of said animal in a substantially pure form, and to the use of said factor to treat hypertension in humans and other animals.
U.S. Patent Number: 4,897,265
Inventors: Ralph J. Stolle, Oregonia, Ohio; Lee R. Beck, Birmingham, Ala.
Date of Patent: January 30, 1990
Method for Treating Disorders of the Vascular and Pulmonary Systems
ABSTRACT: A method for treating vascular disorders or pulmonary disorders associated with smoking in an animal which comprises: administering to the animal milk collected from a bovid being maintained in a hyperimmune state, in an amount and for a time sufficient to produce anti-arteriosclerotic or anti-aging vascular effects or sparing effects on lung tissue.
U.S. Patent Number: 5,106,618
Inventors: Lee R. Beck, Lebanon, Ohio; Donald P. Kotler, New Rochelle, NY.
Date of Patent: April 21, 1992
Method of Treating Protozoal Gastrointestinal Disorders by Administering Hyperimmune Milk Product
ABSTRACT: The invention comprises treatment of gastrointestinal disorders of parasitic protozoan and bacterial origin in immunocompromised and immunocompetent animals by administration of hyperimmune milk product.
U.S. Patent Number: 5,650,175
Inventors: Lee R. Beck, Lebanon, Ohio; J. Peter Fuhrer, Dayton, Ohio
Date of Patent: July 22, 1997
Anti-Inflammatory Factor, Method of Isolation, and Use
ABSTRACT: The invention relates to an anti-inflammatory factor isolated from milk, methods of purifying the anti-inflammatory factor resulting in substantially or highly purified preparations and to methods for using this factor to remove adhered neutrophils from endothelial cells, to prevent the emigration of cells from the vasculature and to suppress the response of lymphocytes to forgoing antigens.
U.S. Patent Number: 5,863,561
Inventors: Lee R. Beck, Lebanon, Ohio; Ralph J. Stolle, Oregonia, Ohio
Date of Patent: January 26, 1999
Immune Suppressive Product
ABSTRACT: An immune suppressive product prepared by injecting an allergen or a mixture of allergens into the body of milk-producing species. Said product being the milk or a polypeptide subfraction of milk obtained from the allergen treated host. The immune suppressive product(s) is milk and or the polypeptide fractions contained therein, which is ostensively free of the intact allergen or allergens used for the treatment of the host. The immune suppressive factor(s) being a subfraction of the allergen used for the treatment. A method of preparing immune suppressive polypeptides from intact allergens, which involves injection of the specific intact allergens into a milk-producing species, collecting the immune suppressive polypeptide fractions of the intact allergens from the milk of the treated host. The immune suppressive milk containing said polypeptide fractions, and/or the polypeptide fractions obtained from said milk, are nonreactive in animals and humans as allergens. Said factor(s), however, are highly effective in preventing or alleviating allergic reactions.
U.S. Patent Number: Reissue 33,565
Inventors: Ralph J. Stolle, Lebanon, Ohio; Lee R. Beck, Birmingham, Ala.
Date of Patent: April 2, 1991
Prevention and Treatment of Rheumatoid Arthritis
ABSTRACT: There is disclosed a novel method and product for the treatment and prevention of rheumatoid arthritis. The method involves passive immunization against a mixed spectrum of infectious bacteria which reside in the human gastrointestinal tract. The passive immunization is accomplished by oral ingestion of IgG immunoglobulin obtained from the milk of cows that have been immunized against a specific spectrum of bacterial types. A unique combination of bacterial species is formulated into a vaccine which is used to immunize dairy cattle. The IgG antibody obtained from the milk of the immunized cows constitutes the product of the invention.
References for Studies with Stolle Milk Products
Beck, L.R., et. al. Milk Lymphocyte Anti-Adhesion Factor, and Its Role as an Antimicrobial. Published in Indigenous Antimicrobial Agents of Milk in Recent Developments. Uppsala: International Dairy Federation; pp. 62-72; 1994.
Golay, A., et. al. Cholesterol-Lowering Effect of Skim Milk from Immunized Cows in Hypercholesterolemic Patients. Am. J. Clin. Nutr. 52: 1014-1019; 1990.
Ishida, A., et. al. Administration of Milk from Cows Immunized with Intestinal Bacteria Protects Mice from Radiation-Induced Lethality. Biotherapy 5. 215-225; 1992.
Ishida, A., et. al. Consumption of Milk from Cows Immunized with Intestinal Bacteria Influences Age-Related Changes in Immune Competence in Mice. J. Nutr. 122; 1875-1883; 1992.
Kobayashi, T., et. al. Protective Effect of Orally Administering Immune Milk on Endogenous Infection in X-Irradiated Mice. Agric. Biol. Chem. 55: 2265-2272; 1991.
Murosaki, S.,et. al. Influence of Intake of Skim Milk from Cows Immunized with Intestinal Bacterial Antigens on Onset of Renal Disease (NZB x NZW)Fj Mice Fed Ad Libitum or Restricted in Energy Intake. J. Nutr. 121: 1860-1868; 1991.
Nomoto, K., et. al. Antibacterial Effect of Bovine Milk Antibody Against Escherichia coli in a Mouse Indigenous Infection Model. Med. Microbiol. Immunol. 181: 87-98; 1992.
Ormrod, D. J., et. al. The Anti-Inflammatory Activity of a Low Molecular Weight Component Derived from the Milk of Hyperimmunized Cows. Agents Actions 32: 160-166; 1991.
Ormrod, D. J., et. al. A Low Molecular Weight Component Derived from the Milk of Hyperimmunized Cows Suppresses Inflammation by Inhibiting Neutrophil Emigration. Agents Actions 37: 70-79; 1992.
Ormrod, D. J., et. al. Milk from Hyperimmunized Cows as a Source of a Novel Biological Response Modifier. Agents Actions 38: C146-C149; 1993.
Owens, W.E., et. al. Evaluation of an Anti-Inflammatory Factor Derived from Hyperimmunized Cows (42832). P.S.E.B.M. 190: 79-86: 1989.
Owens, W.E., et. al. Effect of a Milk-Derived Factor on the Inflammatory Response to Staphylococcus aureus Intramammary Infection. Vet. Immunol. Immunopathol. 30: 233-246; 1992.
Sharpe, S.J., et. al. Cholesterol-Lowering and Blood Pressure Effects of Immune Milk. Am. J. Clin. Nutr. 59: 929-934; 1994.
Woodman, R., et. al. The Effects of Hyperimmunized Milk Factor (HIMF) on Neutrophil Adhesion in Vivo. Abstract; Soc. Leukocyte Biol.; 29th National Meeting; Charleston, S.C.; 1992.