Methods for treating pervasive development disorders

Abstract

A method of utilizing the chymotrypsin level of an individual as a measure of the success of secretin, other neuropeptides, and peptides or digestive enzyme administration to such individuals, and in particular, as a prognosticative of potential secretin, other neuropeptides, peptides, and digestive enzyme administration for persons having ADHD, Autism and other PDD related disorders. In one aspect, a method for determining the efficacy of secretin, other neuropeptides, peptides, or digestive enzymes for the treatment of an individual diagnosed with a pervasive developmental disorder (PDD) comprises obtaining a sample of feces from an individual, determining a quantitative level of chymotrypsin present in the sample, and correlating the quantitative level of chymotrypsin determined to be present in the sample with the PDD to determine the efficacy of treating the individual with secretin, other neuropeptides, peptides, or digestive enzyme administration. In another aspect, a therapeutic method for treating an individual diagnosed with i PDD pervasive developmental disorder comprises determining the efficacy of secretin, other neuropeptides, peptides, and digestive enzyme administration for the treatment of the individual based on a measure of the individual's chymotrypsin level, and administering secretin, other neuropeptides, peptides, or digestive enzymes to the individual based on the determination of the measure of the individual's chymotrypsin level.

Description

RELATED APPLICATIONS

[0001] This application is a Divisional of U.S patent application Ser. No. 10 / 681018, filed on Oct. 8, 2003, which is a Continuation of U.S. Pat. No. 6,632,429 (U.S. patent application Ser. No. 09 / 707,395) filed on Nov. 7, 2000, which is a Continuation-in-Part of U.S. Pat. No. 6,534,063 which was originally application Ser. No. 09 / 466,559, filed on Dec. 17, 1999.FIELD OF INVENTION

[0002] The present invention relates generally to a method for treating individuals diagnosed with a form of PDD (pervasive development disorder) and other disorders such as ADD (attention deficit disorder) and ADHD (attention deficit hyperactivity disorder). More specifically, the present invention is directed to therapeutic method for treating individuals with such disorders by administering secretin, other neuropeptides, peptides, and / or digestive enzymes, as well as a prognosticative method for determining the potential effectiveness of the administration of secretin, other neurope...

Examples

experiment 1

[0038] I. Experiment 1

[0039] In this experiment, 16 children diagnosed as having autism were administered the following Fecal Chymotrypsin Test in accordance with an embodiment of the invention. First, approximately 2 grams of stool were collected from each child and placed in a sterile container (although it is to be understood that any quantity of stool may be collected, as 2 grams of stool is not a required amount). Each stool sample was then analyzed using, e.g., an enzymatic photospectrometry analysis as is known by those skilled in the art, to determine the level of fecal chymotrypsin in the stool. Although the enzymatic photospectrophotometry process is preferred, any suitable conventional method may be used for measuring the fecal chymotrypsin levels. This measured chymotrypsin levels of the 16 autistic children are illustrated in FIG. 13.

[0040] After determining the chymotrypsin levels of the stools, each of these levels were compared with threshold chymotrypsin levels to ...

experiment 2

[0048] II. Experiment 2

[0049] In this experiment, 37 autistic children with abnormal fecal chymotrypsin levels were administered secretin over the course of 6 months using the secretin infusion process described above. Their fecal chymotrypsin (FC) levels were measured weekly using the fecal chymotrypsin test described above.

[0050] Results of Experiment 2

[0051] Out of the 37 autistic children tested, the fecal chymotrypsin levels of 34 children had returned to normal after 6 months, the fecal chymotrypsin levels of 2 children moved to equivocal, and the fecal chymotrypsin level of 1 child remained abnormal. These results of this experiment are listed in the following Table 1.

TABLE IPre-Secretin6 Months Post-Administra-SecretinAutistic Children TestedtionAdministration# Autistic Children w / Abnormal FC levels371# Autistic Children w / Equivocal FC levels02# Autistic Children w / normal FC levels034

experiment 3

[0052] III. Experiment 3

[0053] In this experiment, the fecal chymotrypsin levels of 28 children diagnosed with ADD were obtained using the fecal chymotrypsin test described above in Experiment 1. FIG. 15 illustrates the measured fecal chymotrypsin levels of these 28 children. It is to be noted that, as shown in FIG. 15, all of the 28 ADD children were found to have sub-normal fecal chymotrypsin levels since all of the values fell below 8.4 U / g. More specifically, 8 out of 28 children were determined to have an equivocal fecal chymotrypsin level and 20 out of the 28 children were determined to have a pathologic level of fecal chymotrypsin. As noted above, a chymotrypsin level of 8.4 U / g is considered a reference value for normal levels of chymotrypsin.

[0054] Of these 28 children who were diagnosed with ADD and abnormal fecal chymotrypsin levels, 10 were administered digestive enzymes comprising amylase, proteases, lipases, sucrase, maltase, and other digestive enzymes. These digesti...

RELATED APPLICATIONS

[0001] This application is a Divisional of U.S patent application Ser. No. 10 / 681018, filed on Oct. 8, 2003, which is a Continuation of U.S. Pat. No. 6,632,429 (U.S. patent application Ser. No. 09 / 707,395) filed on Nov. 7, 2000, which is a Continuation-in-Part of U.S. Pat. No. 6,534,063 which was originally application Ser. No. 09 / 466,559, filed on Dec. 17, 1999.FIELD OF INVENTION

[0002] The present invention relates generally to a method for treating individuals diagnosed with a form of PDD (pervasive development disorder) and other disorders such as ADD (attention deficit disorder) and ADHD (attention deficit hyperactivity disorder). More specifically, the present invention is directed to therapeutic method for treating individuals with such disorders by administering secretin, other neuropeptides, peptides, and / or digestive enzymes, as well as a prognosticative method for determining the potential effectiveness of the administration of secretin, other neurope...

Examples

experiment 1

[0038] I. Experiment 1

[0039] In this experiment, 16 children diagnosed as having autism were administered the following Fecal Chymotrypsin Test in accordance with an embodiment of the invention. First, approximately 2 grams of stool were collected from each child and placed in a sterile container (although it is to be understood that any quantity of stool may be collected, as 2 grams of stool is not a required amount). Each stool sample was then analyzed using, e.g., an enzymatic photospectrometry analysis as is known by those skilled in the art, to determine the level of fecal chymotrypsin in the stool. Although the enzymatic photospectrophotometry process is preferred, any suitable conventional method may be used for measuring the fecal chymotrypsin levels. This measured chymotrypsin levels of the 16 autistic children are illustrated in FIG. 13.

[0040] After determining the chymotrypsin levels of the stools, each of these levels were compared with threshold chymotrypsin levels to ...

experiment 2

[0048] II. Experiment 2

[0049] In this experiment, 37 autistic children with abnormal fecal chymotrypsin levels were administered secretin over the course of 6 months using the secretin infusion process described above. Their fecal chymotrypsin (FC) levels were measured weekly using the fecal chymotrypsin test described above.

[0050] Results of Experiment 2

[0051] Out of the 37 autistic children tested, the fecal chymotrypsin levels of 34 children had returned to normal after 6 months, the fecal chymotrypsin levels of 2 children moved to equivocal, and the fecal chymotrypsin level of 1 child remained abnormal. These results of this experiment are listed in the following Table 1.

TABLE IPre-Secretin6 Months Post-Administra-SecretinAutistic Children TestedtionAdministration# Autistic Children w / Abnormal FC levels371# Autistic Children w / Equivocal FC levels02# Autistic Children w / normal FC levels034

experiment 3

[0052] III. Experiment 3

[0053] In this experiment, the fecal chymotrypsin levels of 28 children diagnosed with ADD were obtained using the fecal chymotrypsin test described above in Experiment 1. FIG. 15 illustrates the measured fecal chymotrypsin levels of these 28 children. It is to be noted that, as shown in FIG. 15, all of the 28 ADD children were found to have sub-normal fecal chymotrypsin levels since all of the values fell below 8.4 U / g. More specifically, 8 out of 28 children were determined to have an equivocal fecal chymotrypsin level and 20 out of the 28 children were determined to have a pathologic level of fecal chymotrypsin. As noted above, a chymotrypsin level of 8.4 U / g is considered a reference value for normal levels of chymotrypsin.

[0054] Of these 28 children who were diagnosed with ADD and abnormal fecal chymotrypsin levels, 10 were administered digestive enzymes comprising amylase, proteases, lipases, sucrase, maltase, and other digestive enzymes. These digesti...

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