Method of Treating Protozoal Gastrointestinal Disorders in Immunocompromised Patients
AssigneeStolle Milk Biologics, Inc.
InventorsJoseph Whelihan, Jada Eley
Life of this patent
Estimating the term…
Abstract
The invention relates to a method for treating protozoal gastrointestinal disorders in immunocompromised patients. It includes a method for the isolation of a factor from the milk of hyperimmunized animals in a substantially pure form, and to the use of said factor in combination with vitamins and minerals.
Claims19
A method of treating cryptosporidiosis or isosporiasis in an immunocompromised animal which comprises:
- administering to said immunocompromised animal a product comprised of a vitamin and mineral blend (Vitamins B1, B2, B6, B12, Folate, D3, C, E, and minerals Magnesium and Zinc), probiotics, including but not limited to Lactobacillus and Bifidobacterium species, mixed with a hyperimmune milk product containing a biologically active component which reduces a number of oocysts in a stool, reduces a number of Cryptosporidia or Isospora parasites in an intestine or alleviates symptoms of cryptosporidiosis or isosporiasis in a subject infected with Cryptosporidia or Isospora from a hyperimmunized milk-producing mammal selected from the group consisting of cows, sheep, and goats, in amounts sufficient to treat said cryptosporidiosis or isosporiasis, wherein said hyperimmune milk product is selected from the group consisting of hyperimmune whole milk, hyperimmune whole milk fractions, and derivatives of hyperimmune whole milk which contain said biologically active component and is prepared by a process comprising:
- (i) hyperimmunizing said milk-producing mammal with a mixture of non-protozoan bacterial antigens;
- (ii) collecting milk from said milk-producing mammal after said milk-producing mammal reaches a hyperimmune state;
- (iii) filtering said milk through a molecular sieve which excludes proteins of molecular weight greater than 100,000 daltons;
- (iv) blending said filtered milk retentate with the said vitamin and mineral blend and probiotics;
- and
- (v) testing the blend of step (iv) for its ability to reduce the number of oocysts in the stool, reduce the number of Cryptosporidia or Isospora parasites in the intestine or alleviate symptoms of cryptosporidiosis or isosporiasis in a subject infected with Cryptosporidia or Isospora by administering to said subject the blend of step (iv) and measuring the reduction of said oocysts, parasites, or symptoms.
A method of treating cryptosporidiosis or isosporiasis in an immunocompromised patient which comprises:
- orally administering to said patient a blend of vitamins, minerals, probiotics, and hyperimmune milk product from a hyperimmunized milk-producing bovid in amounts sufficient to treat said cryptosporidiosis or isosporiasis, wherein said hyperimmune milk product is prepared by a process comprising:
- i. intramuscularly hyperimmunizing said bovid with an injection of a microencapsulated slow-release vaccine wherein said vaccine comprises a mixture of nonprotozoan bacterial antigens selected from the group consisting of Staphylococcus aureus;
- Staphylococcus epidermidis;
- Streptococcus pyogenes, A. Type 1;
- Streptococcus pyogenes, A. Type 3;
- Streptococcus pyogenes, A. Type 5;
- Streptococcus pyogenes, A. Type 8;
- Streptococcus pyogenes, A. Type 12;
- Streptococcus pyogenes, A. Type 14;
- Streptococcus pyogenes, A. Type 18;
- Streptococcus pyogenes, A. Type 22;
- Aerobacter aerogenes;
- Escherichia coli;
- Pseudomonas aeruginosa;
- Klebsiella pneumoniae;
- Salmonella typhimurium;
- Haemophilus influenzae;
- Streptococcus mitis;
- Proteus vulgaris;
- Shigella dysenteriae;
- Diplococcus pneumoniae;
- Propionibacter acnes;
- Streptococcus mutans;
- and Streptococcus agalactiae;
- ii. collecting the milk from said bovid after said bovid reaches a hyperimmune state;
- iii. pasteurizing said collected milk under low temperature at reduced pressure;
- iv. removing the fat from said pasteurized milk;
- v. filtering said defatted milk through molecular sieves which excludes proteins of molecular weight greater than 100,000;
- and
- vi. concentrating the milk proteins in the retentate of said sieve approximately 30-fold and blending with vitamins, minerals, and probiotics prior to administration to said immunocompromised patient.
The method of claim 3 wherein said immunocompromised animal is a human.
The method of claim 9 wherein said retentate is concentrated greater than 10-fold.
The method of claim 13 wherein said oral dose comprises 106 to 1020 cells.
The method of claim 18 wherein said periodic administration is by oral means.
The method of claim 18 wherein said periodic administration is by intranasal means.
Dependencies are inferred from the claim text.