Claims
- 1. A hypoallergenic composition for the induction of protein tolerance in at risk individuals of protein allergy, containing (i) an extensively hydrolyzed “non allergenic” protein material or (ii) a free amino acid basis, wherein the composition includes, as an active ingredient, at least one tolerogenic peptide of the allergenic protein in an amount sufficient to induce oral tolerance.
- 2. The composition of claim 1, wherein the tolerogenic peptide is present in the form of (i) one or more isolated tolerogenic peptidic fractions resulting from the hydrolysis of proteinaceous material containing the allergenic protein or (ii) one or more synthetically prepared tolerogenic peptides.
- 3. The composition of claim 2, wherein the synthetically prepared tolerogenic peptide or isolated peptide fraction is present in an amount to provide a ratio of tolerogenic activity by residual antigenicity of at least about 2×10−2.
- 4. The composition of claim 1, which contains an amount of tolerogenic peptide of about 0.01% to 10% of the total nitrogen source of the proteins in the composition.
- 5. The composition of claim 1, which contains an amount of tolerogenic peptide of about 0.1% to 0.2% of the total nitrogen source of the proteins in the composition.
- 6. The composition of claim 1, wherein the tolerogenic peptidic is one or more peptide fractions comprising H2N-I-D-A-L-N-E-N-K-COOH, H2N-V-L-V-L-D-T-D-Y-K,-K-COOH or H2N-T-P-E-V-D-D-E-A-L-E-K-F-D-K-COOH from β-lactoglobulin.
- 7. The composition of claim 1, which further comprises a source of nitrogen providing 7 to 25% of the total energy, a source of carbohydrates which provides 28 to 66% of the total energy, a source of lipids which provides 25 to 60% of the total energy, minerals and vitamins to meet daily requirements and at least one of the tolerogenic peptides that is added in an efficient quantity so as to induce oral tolerance.
- 8. A method for the preparation of a hypoallergenic composition intended for administration to mammals susceptible to cow's milk allergy, which comprises incorporating into such composition, as an active ingredient which induces tolerance to milk proteins, an effective amount of a tolerogenic peptide of a milk protein.
- 9. The method of claim 8, wherein the tolerogenic peptide is at least one tolerogenic peptide of the allergenic protein.
- 10. The method of claim 8, wherein the tolerogenic peptide is from milk origin.
- 11. The method of claim 10, wherein the tolerogenic peptide is from β-lactoglobulin, α-lactalbumin, bovin serum albumin or casein origin.
- 12. The method of claim 8, wherein the tolerogenic peptide comprises: H2N-I-D-A-L-N-E-N-K-COOH, H2N-V-L-V-L-D-T-D-Y-K,-K-COOH or H2N-T-P-E-V-D-D-E-A-L-E-K-F-D-K-COOH from β-lactoglobulin.
- 13. The method of claim 8, wherein the composition contains a source of nitrogen which provides 7 to 25% of the total energy, a source of carbohydrates which provides 28 to 66% of the total energy, a source of lipids which provides 25 to 60% of the total energy, and, optionally, minerals and vitamins to meet daily requirements.
- 14. The method of claim 13, wherein the effective amount of the tolerogenic peptide is at least about 0.01% to 10% of the total nitrogen source of the protein.
- 15. The method of claim 8, wherein the tolerogenic peptides are present in an amount such that the ratio of tolerogenic activity to residual antigenicity is at least about 2×10−2.
- 16. A method of preparation of tolerogenic peptide useful in the induction of protein tolerance in at risk individuals to protein allergy, wherein:
(i) a proteinaceous material containing the allergenic protein is hydrolyzed to a degree of hydrolysis of about 10 to 50%; (ii) then treated to inactivate residual enzyme activity; and (iii) the protein hydrolysate solution is clarified and submitted to precipitation treatment or passed into a chromatography column filled with appropriated resin to extract tolerogenic peptidic fractions.
- 17. The method of claim 16, wherein tolerogenic peptidic fractions are concentrated to a dry solids content of about 35-65% and spray dried.
Priority Claims (1)
Number |
Date |
Country |
Kind |
99200130.5 |
Jan 1999 |
EP |
|
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of the U.S. national phase designation of International Application no. PCT/EP00/00334 filed Jan. 17, 2000, the content of which is expressly incorporated herein by reference thereto.
Continuations (1)
|
Number |
Date |
Country |
Parent |
PCT/EP00/00334 |
Jan 2000 |
US |
Child |
09907109 |
Jul 2001 |
US |