IP Library Granted Patent US 10,350,229
Granted Patent B2
US 10,350,229 · App. 15/089,842 · Granted Jul 16, 2019

Use of lactulose in the treatment of autism

Inventors: Joan M. Fallon (Bronxville, NY); Richard Feltenstein (New Rochelle, NY)
Assignee: Curemark, LLC
A61K31/7016A61K31/045A61K31/047A61K31/7012
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Quick Facts
Patent No.
US 10,350,229
App. No.
15/089,842
Granted
Jul 16, 2019
Kind
B2
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 (13)

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.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME, HAVE COMMA PREVIOUSLY RECORDED AT REEL: 038194 FRAME: 0680. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jan 18, 2017
From: FALLON, JOAN M.; FELTENSTEIN, RICHARD
To: CUREMARK, LLC
Reel/Frame 041440/0197 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2016
From: FALLON, JOAN M.; FELTENSTEIN, RICHARD
To: CUREMARK LLC
Reel/Frame 038194/0680 →
Continuity (5)
Continuation 14087930 · Nov 22, 2013
Continuation 13204881 · Aug 8, 2011
Division 12049613 · Mar 17, 2008
Division 11468379 · Aug 30, 2006
Related Publication 20160213697A1 · Jul 28, 2016
Cited By (2)
US 12,226,464 US 12,485,094