# Patent

## Title
Composition of a liquid dietary supplement to treat symptoms of autism spectrum disorders in children

## Abstract

The object of the present invention is to provide an all-natural dietary supplement formulation that may be beneficial to the management of behavioral and neurological symptoms associated with autism spectrum disorders; symptoms that may not be effectively improved by conventional drug treatment and behavioral therapy alone.

## Background
The present invention claims priority to U.S. provisional application 61/028,328 filed Feb. 13, 2008. This invention relates to a composition of a liquid dietary supplement to treat symptoms often displayed by children who have been diagnosed with an autism spectrum disorder.


SUMMARY
The product is comprised of the water-soluble extract of mastic gum, theanine, Passionflower extract, Feverfew extract and vitamin B6.
The present invention aims to improve the behavioral and neurological symptoms of autism spectrum disorders by targeting the areas that are most commonly affected in children with autism spectrum disorders, such as: social behavior, intestinal functioning, sleep, anxiety and brain neuropathy.
The present invention is a dietary supplement in the form of a syrup that is given to the child once to twice a day at a dose of about 1 to about 3 teaspoon(s) (about 5 to about 15 ml), based on the child's age. The syrup can be mixed with a beverage if needed. The same objective may be reached with a chewable tablet, capsule, gel cap, lollipop, lozenge, powder or effervescent tablet that contains the same formulation as the liquid formulation.


DESCRIPTION
The present invention relates to a composition of a liquid dietary supplement to treat symptoms of autism spectrum disorders in children.
The product is comprised of the following components:

    
    
        (1) Mastic Gum: The present formulation contains the water-soluble extract of mastic gum at a final concentration of about 5 to about 100 mg/ml. Based on scientific studies, mastic gum, a resin from the mastic tree (Pistacia lentiscus) found primarily on the Greek island of Chios, can effectively eradicate the bacterium H. pylori in the gut (Huwez et al., 1998) and acts as an anti-inflammatory substance (Aksoy et al., 2006).
        (2) Theanine: The present formulation contains theanine at a concentration of about 1 to about 10 mg/ml. Theanine, an amino acid commonly found in tea, easily crosses the blood-brain barrier. It has been found to reduce stress and to promote a more restful deep sleep.
        (3) Passionflower extract: The present formulation contains Passionflower extract at a concentration of about 5 microgram/ml to about 100 microgram/ml. Passionflower extract has a long history of use among Native Americans in North America. It is commonly used to treat insomnia, hysteria and epilepsy and may also be effective for anxiety.
        (4) Feverfew extract: The present formulation contains Feverfew extract at a concentration of about 5 microgram/ml to about 100 microgram/ml. Feverfew is a medicinal extract that is often used to treat migraines and digestive problems.
        (5) Vitamin B6: The present formulation contains Vitamin B6 at a concentration of about 200 microgram/ml to about 10 mg/ml. Vitamin B6 is a water-soluble compound that can exists as three forms in the body. All three forms of vitamin B6 are precursors of an activated compound known as pyridoxal 5′-phosphate (PLP), which plays a vital role as the cofactor of a large number of essential enzymes in the human body.
    
    


The present invention aims to alleviate or reverse the various symptoms of autism by targeting the various areas that are affected in autism spectrum disorders:

    
    
        (1) Improved gut functioning:
        
            It has long been suggested that improper bowel function and inflammation in the gut are partly responsible for the behavioral symptoms of autism (White 2003, Parracho et al., 2005, Jyonouchi et al., 2005). Many neuropeptides are synthesized in the gut and are important for proper brain functioning.
            The synthesis and/or the absorption of these neuropeptides in the gut may be compromised by inflammatory processes in the intestines of individuals with autism.
            Mastic Gum and Feverfew extracts are included in the present formulation to aid in the proper functioning of the intestines, thereby improving normal brain function. The present inventor has found that a formulation including mastic gum improves social behavior in children with autism.
        
        
        (2) Improved sleep patterns:
        
            Since many children with autism spectrum disorders have disturbed sleep patterns, the present inventor included theanine and passionflower extracts in the formulation.
            The reasoning behind this is that a well-rested child will function better in daily life.
        
        
        (3) Decreased anxiety:
        
            Many children with autism show increased levels of anxiety combined with high frustration levels, both of which interfere with social behavior.
            The Passionflower extract in the present formulation aims to decrease anxiety.
        
        
        (4) Brain Neuropathy
        
            Vitamin B6 deficiency is believed to result in the development of neuropathy (For review, see Clayton (2006)).
            Studies have shown that in individuals diagnosed with autism, high doses of vitamin B6 given with magnesium have been found to be extremely beneficial (Nye and Brice (2005)).
        
        
    
    


The present invention is a dietary supplement in the form of a syrup that is given to the child once or twice a day at a dose of about 1 to about 3 teaspoon(s) (about 5 to about 15 ml), based on the child's age. The syrup can be mixed with a beverage if needed. The same objective may be reached with a chewable tablet, capsule, gel cap, lollipop, lozenge, powder or effervescent tablet that contains the same formulation as the liquid formulation.
The present formulation may also be beneficial in treating and alleviating the symptoms of other neurological disorders, where a relationship exists between improper intestinal functioning and (brain) neuropathy.
OTHER REFERENCES


    1. Aksoy, A., Duran, N. and Koksal, F. (2006) In vitro and in vivo antimicrobial effects of mastic chewing gum against Streptococcus mutans and mutans streptococci. Arch. Oral Biol. 51:476-81.
    2. Clayton, P. T. (2006) B6-responsive disorders: a model of vitamin dependency. J. Inherit. Metab. Dis. 29:317-26.
    3. Demestre, M., Messerli, S., Shahhossini, M., Kluwe, L., Mautner, V. and Maruta, H. (2007) Signal Therapy of NF (Neurofibromatosis) by Natural PAK1 Blockers. NF Conference, Abstract.
    4. Hayashi, M. L., Rao, B. S., Seo, J. S., Choi, H. S., Dolan, B. M., Choi, S. Y., Chattarji, S. and Tonegawa, S. (2007) Inhibition of p21-activated kinase reescues symptoms of fragile X syndrome in mice. Proc. Natl. Acad. Sci. USA. 104:11489-94.
    5. Huwez, F. U., Thirlwell, D., Cockayne, A. and Ala'Aldeen, D. A. (1998) Mastic gum kills Helicobacter pylori. N Engl. J. Med. 339:1946.
    6. Jyonouchi, H., Geng, L., Ruby, A. and Zimmerman-Bier, B. (2005) Dysregulated innate immune responses in young children with autism spectrum disorders: their relationship to gastrointestinal symptoms and dietary intervention. Neuropsychobiol. 51:77-85.
    7. Nye, C. and Brice, A. (2005) Combined vitamin B6-magnesium treatment in autism spectrum disorder. Cochrane Database Syst. Rev. 4: CD003497.
    8. Parracho, H. M., Bingham, M. O., Gibson, G. R., and McCartney, A. L. (2005) Differences between the gut microflora of children with autistic spectrum disorders and that of healthy children. J. Med. Microbiol. 54:987-91.
    9. White, J. F. (2003) Intestinal pathophysiology in autism. Exp. Biol. Med. 228:639-49.

## Claims

1. A formulation for treating symptoms of autism comprising effective amounts of:
water-soluble a extract of mastic gum;
L-Theanine;
Passionflower a extract;
Feverfew a extract; and
Vitamin B6.

2. The formulation of claim 1 wherein a concentration of said water-soluble extract of mastic gum is between 5 to 100 mg/ml.

3. The formulation of claim 1 wherein a concentration of said L-Theanine is between 1 to 10 mg/ml.

4. The formulation of claim 1 wherein a concentration of said Passionflower extract is between 5 to 100 microgram/ml.

5. The formulation of claim 1 wherein a concentration of said Feverfew extract between 5 to 100 microgram/ml.

6. The formulation of claim 1 wherein a concentration of said vitamin B6 is between about 200 microgram/ml to about 10 mg/ml.

7. The formulation of claim 1 wherein a concentration of said water-soluble extract of mastic gum is between 5 to 100 mg/ml, and a concentration of said L-Theanine is about 1 to 10 mg/ml.

8. The formulation of claim 1 wherein a concentration of said water-soluble extract of mastic gum is between 5 to 100 mg/ml, a concentration of said L-Theanine is about 1 to 10 mg/ml, a concentration of said Passionflower extract is between 5 to 100 microgram/ml, a concentration of said Feverfew extract between 5 to 100 microgram/ml, and a concentration of said vitamin B6 is between about 200 microgram/ml to about 10 mg/ml.

9. The formulation of claim 1 wherein said formulation consists essentially of:
said water-soluble extract of mastic gum;
said L-Theanine;
said Passionflower extract;
said Feverfew extract; and
said Vitamin B6.

10. The formulation of claim 1 wherein said formulation consists essentially of:
said water-soluble extract of mastic gum;
said L-Theanine;
said Passionflower extract;
said Feverfew extract; and
said Vitamin B6; and

wherein a concentration of a said water-soluble extract of mastic gum is between 5 to 100 mg/ml, a concentration of said L-Theanine is about 1 to 10 mg/ml, a concentration of said Passionflower extract is between 5 to 100 microgram/ml, a concentration of said Feverfew extract between 5 to 100 microgram/ml, and a concentration of said vitamin B6 is between about 200 microgram/ml to about 10 mg/ml.

11. The formulation of claim 1 wherein said formulation is in a dosage form selected from the group consisting of: a drink, a drink comprised of water, a syrup, a tablet, a gelcap, a capsule, a lozenge, a lollipop, a powder, and an effervescent tablet.

12. A method of treating a subject having at least some of the behavioral symptoms of autism spectrum disorders, comprising orally administering an effective amount of the formulation according to claim 1 to said subject.