Use of lactulose in the treatment of autism

• US 10,350,229 B2
• Filed: 04/04/2016
• Issued: 07/16/2019
• Est. Priority Date: 08/30/2005
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M., Feltenstein, Richard
• Primary Examiner(s): Berry, Layla D
• Application Number:
  US15/089,842
• Publication Number:
  US 20160213697A1
• Time in Patent Office: 1,198 Days
• Field of Search: None
• CPC Class Codes: A61K 31/045 Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 31/7012 Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid gluconic acid A61K31/191; ascorbic acid A61K31/375
• CPC Class Codes: A61K 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A treatment for autism in which an effective amount of lactulose is administered in order to bind excess ammonia in the gastrointestinal tract, the bloodstream, and the nervous system in order to prevent or reverse ammonia poisoning caused by the administration of certain antibiotics. Lactulose molecules in the colon are fermented by certain bacteria. The fermentation process lowers the colonic pH, and ammonia, in the form of ammonium ions, is used by the bacteria for amino acid and protein synthesis. This lowers the serum ammonia levels and reduces neurotoxicity.

Claims

1. A method for increasing a bacterial biomass in a colon of an individual diagnosed with an autistic disorder, comprising administering to the individual an effective amount of lactulose and an effective amount of mannitol, thereby increasing the bacterial biomass in the colon of the individual, wherein the method does not include administration of an antibiotic to the individual.

2. The method of claim 1, wherein the effective amount of lactulose comprises about 0.4 g/kg lactulose per dose.

3. The method of claim 1, wherein the effective amount of lactulose comprises about 0.3 g/kg lactulose per dose.

4. The method of claim 1, wherein the effective amount of lactulose is administered to the individual approximately two to five times per day.

5. The method of claim 1, wherein the effective amount of lactulose is administered to the individual in a form selected from the group consisting of a powder, a liquid solution, and a combination thereof.

6. The method of claim 1, wherein the effective amount of lactulose includes an amount of lactulose sufficient to decrease ammonia levels in the blood of the individual.

7. The method of claim 1, wherein the effective amount of lactulose includes an amount of lactulose sufficient to decrease ammonia levels in a gastrointestinal tract of the individual.

8. The method of claim 1, wherein the effective amount of lactulose includes an amount of lactulose sufficient to decrease ammonia levels in a nervous system of the individual.

9. The method of claim 1, wherein the effective amount of lactulose includes an amount of lactulose sufficient to reverse ammonia poisoning caused by the administration of antibiotics that leave a residue in a gastrointestinal tract of the individual.

10. The method of claim 1, wherein the effective amount of lactulose is fermented by bacteria in a colonic tract of the individual.

11. The method of claim 10, wherein fermentation lowers a colonic pH of the individual.

12. The method of claim 1, wherein the effective amount of mannitol comprises about 0.1 g/kg mannitol per dose.

13. The method of claim 1, wherein the bacterial biomass comprises lactobacilli and bifidobacteria.