Use of lactulose in the treatment of autism

• US 9,345,721 B2
• Filed: 11/22/2013
• Issued: 05/24/2016
• 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
• Application Number:
  US14/087,930
• Publication Number:
  US 20140187512A1
• Time in Patent Office: 914 Days
• US Class Current: 1/1
• 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 treating an individual diagnosed with an autistic disorder, the method comprising administering a therapeutically effective amount of lactulose and mannitol to the individual, wherein administration of the lactulose follows administration of an antibiotic, and wherein administration of lactulose increases the number of lactobacilli and bifidobacteria in a gut flora.

2. The method of claim 1, wherein the individual has a gastrointestinal disorder, a neurological disorder, or a combination thereof.

3. The method of claim 1, wherein the lactulose is administered in an amount of about 0.4 g/kg lactulose per dose.

4. The method of claim 1, wherein the lactulose is administered in an amount of about 0.3 g/kg lactulose per dose.

5. The method of claim 1, wherein the lactulose is administered approximately two to five times per day.

6. The method of claim 1, wherein the lactulose is administered in a form selected from the group consisting of a powder, a liquid solution, a syrup, and a combination thereof.

7. The method of claim 1, wherein a level of ammonia is decreased in the blood of the individual.

8. The method of claim 1, wherein a level of ammonia is decreased in the gastrointestinal tract of the individual.

9. The method of claim 1, wherein a level of ammonia is decreased in the nervous system of the individual.

10. The method of claim 1, wherein the lactulose reverses ammonia poisoning caused by the administration of antibiotics that leave a residue in the gastrointestinal tract of the individual.

11. The method of claim 1 wherein the mannitol is administered in an amount of about 0.1 g/kg mannitol per dose.

12. The method of claim 1, wherein administration of the lactulose immediately follows administration of the antibiotic.

13. The method of claim 1, wherein the antibiotic is amoxicillin-clavulanate.