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References On
GalaGen's Immune Ingredients

Related Topics: Summary of
Scientific Evidence

Part 1
Bovine Immunoglobulins for
Treatment and Prevention
of Specific Conditions

The following annotated references describe peer-reviewed research studies on the safety and efficacy of GalaGen’s immune components from bovine colostrum.

R. A. Hoerr and E.F. Bostwick. 2000. Bioactive Proteins and Probiotic Bacteria: Modulators of Nutritional Health. Nutrition 16, 7/8.


M. Warny, A. Fatimi, E.F. Bostwick, D.C. Laine, F. Lebel, J.T. LaMont, C. Pothoulakis, C.P. Kelly. 1999. Bovine immunoglobulin concentrate-Clostridium difficile retains C. difficile toxin neutralizing activity after passage through the human stomach and small intestine. Gut 44:212-217.

When human volunteers consumed an immunoglobulin concentrate prepared from bovine colostrum, biologically active antibodies were recovered from ileal fluid. An average of 49% of the ingested dose of bovine IgG was detected in ileal fluid effluent within a 6 hr collection period. Recovered antibodies neutralized the biological activity of C. difficile toxin A in a tissue culture cytotoxicity assay. Other researchers have reported varying rates of recovery of intact bovine IgG from ileal fluids and feces in adults and children.

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J. Tollemar, N. Gross, N. Dolgiras, C. Jarstrand, O. Ringdén and L. Hammarström. 1999. Fungal prophylaxis by reduction of fungal colonization by oral administration of bovine anti-Candida antibodies in bone marrow transplant recipients. Bone Marrow Transpl. 23:283-290.

Administration of bovine immunoglobulins to bone marrow transplant patients reduced Candida colonization in a majority of patients with high (>100 cfu/g) initial colonization levels. Product, prepared from the colostrum of cows immunized against C. albicans, was administered as a ‘swish and swallow’ formula 3 times daily beginning 4 days prior to transplant. No systemic uptake of bovine immunoglobulins and no adverse events were reported in these severely immunocompromised patients.

T.K. Graczyk, M.R. Cranfield, and E.F. Bostwick. 1999. Hyperimmune bovine colostrum treatment of moribund Leopard geckos (Eublepharis macularius) infected with Cryptosporidium sp. Vet. Res. 30:377-382.

Bovine colostral antibodies, with activity directed against Cryptosporidium parvum, significantly decreased the parasite burden in geckos maintained at the Baltimore Zoo. Typically, cryptosporidial infection causes wasting and high death rates in geckos, but 7 treatments at one-week intervals decreased oocyst output in stools, eliminated gastric infection, and markedly decreased mortality in geckos that had already lost more than 50% of their body weight.

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T.K. Graczyk, M.R. Cranfield, P. Helmer, R. Fayer, and E.F. Bostwick. 1998. Therapeutic efficacy of hyperimmune bovine colostrum treatment against clinical and subclinical Cryptosporidium serpentis infections in captive snakes. Vet. Parasitol. 71:123-132.

Bovine colostral antibodies have repeatedly demonstrated efficacy across species. Antibodies with specific activity against Cryptosporidium parvum significantly improved the health of snakes with clinical and subclinical cryptosporidial infections. Exotic snakes at the Baltimore Zoo were treated 6 times at weekly intervals by gastric lavage. Colostrum therapy produced oocyst-negative stools and negative gastric lavage samples in all treated snakes.

C.P. Kelly, S. Chetham, S. Keates, E.F. Bostwick, A.M. Roush, I. Castagliuolo, J.T. LaMont and C. Pothoulakis. 1997. Survival of anti-Clostridium difficile bovine immunoglobulin concentrate in the human gastrointestinal tract. Antimicrobial Agents and Chemother. 41;236-241.

Filtrates of stool samples from human volunteers ingesting bovine colostrum immunoglobulin preparations specifically neutralized the activity of C. difficile toxins A and B. Recovery of bovine IgG following gastrointestinal passage was similar between fasted and fed subjects, and was inversely correlated with intestinal transit time. The co-administration of omeprazole, a proton pump inhibitor, further enhanced IgG survival.

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P.D. Greenberg and J.P. Cello. 1996. Treatment of severe diarrhea caused by Cryptosporidium parvum with oral bovine immunoglobulin concentrate in patients with AIDS. J. AIDS and Hum. Retrovirol. 13:348-354.

AIDS patients with chronic C. parvum diarrhea who received a powdered formulation of concentrated bovine immunoglobulins experienced a significant reduction in stool weight and frequency, and body weight stabilized during treatment. While several prior small clinical studies have suggested a role for passive immunotherapy with bovine colostrum, this was the largest pilot study published to date. No serious side effects were observed and product was well tolerated despite dosages up to 40 g of immunoglobulin concentrate per day.

C.P. Kelly, C. Pothoulakis, F. Vavva, I. Castagliuolo, E.F. Bostwick, J.C. O'Keane, S. Keates and J.T. LaMont. 1996. Anti-Clostridium difficile bovine immunoglobulin concentrate inhibits cytotoxicity and enterotoxicity of C. difficile toxins. Antimicrobial Agents and Chemother. 40:373-379.

Orally administered bovine antibodies from colostrum of cows immunized against C. difficile have been proposed for prophylactic and/or therapeutic treatment of antibiotic-associated diarrhea. Various in vitro models were used to demonstrate the specific ability of bovine immunoglobulins to inhibit both the cytotoxic and enterotoxic actions of clostridial toxins A and B. In an in vivo rat ileal loop model, antibodies also protected against intestinal mucosal damage and completely blocked mannitol permeability.

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C.O. Tacket, S.B. Binion, E.F. Bostwick, G. Losonsky, M.J. Roy and R. Edelman. 1992. Efficacy of bovine milk immunoglobulin concentrate in preventing illness after Shigella flexneri challenge. Amer. J. Trop. Med. Hyg. 47:276-283.

Bovine immunoglobulins with specific activity against Shigella flexneri completely protected healthy volunteers in a disease challenge study. Prophylactic efficacy was directly correlated with antibody titer. Antibodies survived gastrointestinal passage to prevent attachment and/or colonization in the large intestine. Shedding of live challenge organisms in the feces was also decreased in treated subjects. Shigellosis is a diarrheal disease frequently seen in institutional settings, and in travelers and military personnel in developing countries; symptoms result from exposure to as few as 10 organisms.

N. Takahashi, G. Eisenhuth, I. Lee, C. Schachtele, N. Laible and S. Binion. 1992. Nonspecific antibacterial factors in milk from cows immunized with human oral bacterial pathogens. J. Dairy Sci. 75:1810-1820.

In addition to the naturally occurring, broad-spectrum antibodies, colostrum contains a variety of other biologically active components that provide passive protection against disease-causing organisms. Various combinations of these components may react synergistically to help control pathogens. Lactoperoxidase, the most abundant antimicrobial enzyme in milk, and lysozyme were particularly effective against oral Actinomyces. Other oral pathogens, P. gingivalis, Fusobacterium and Strep. sanguis were more significantly inhibited by colostral lactoferrin.

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N. Takahashi. G. Eisenhuth, I. Lee, N. Laible, S. Binion and C. Schachtele. 1992. Immunoglobulins in milk from cows immunized with oral strains of Actinomyces, Prevotella, Porphyromonas and Fusobacterium. J. Dent. Res. 71: 1509-1515.

High titer bovine colostral antibodies can be specifically targeted against human pathogens with minimal crossreactivity across genera. Immunization regimens can de designed to direct the immune response to single strains or multiple related organisms of interest. This exquisite sensitivity allows immunoglobulin preparations to be used without concern for disruption of desirable endogenous microflora.

D.M. Lyerly, E.F. Bostwick, S.B. Binion and T.D. Wilkins. 1991. Passive immunization of hamsters against disease caused by Clostridium difficile by use of bovine immunoglobulin G concentrate. Infect. Immun. 59:2215-2218.

Orally administered bovine antibodies, from colostrum of specifically immunized cows, successfully protected golden Syrian hamsters from a lethal challenge with C. difficile organisms. Non-immune colostrum with or without delivery vehicle (infant feeding formula) did not prevent development of diarrhea and fatal cecitis. When treatment was stopped disease symptoms appeared, suggesting that the mechanism of action was via inhibition of toxins rather than through bactericidal activity.
Related Topics: Summary of
Scientific Evidence

Part 1
Bovine Immunoglobulins for
Treatment and Prevention
of Specific Conditions
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