Title: Method for diagnosing and treating dysautonomia and other dysautonomic conditions
United States Patent: 6,660,831
Issued: December 9, 2003
Inventors: Fallon; Joan M. (1284 Central Ave., Suite 1B, Yonkers, NY 10704)
Appl. No.: 929592
Filed: August 14, 2001
Methods for aiding in the diagnosis of dysautonomic disorders and dysautonomic conditions and methods for treating individuals diagnosed as having a dysautonomic disorder or a dysautonomic condition. In one aspect, a diagnosis method comprising analyzing a stool sample of an individual for the presence of a biological marker wherein the quantity of the biological marker is an indication of whether the invidual has, or can develop, a dysuatonic disorder or dysautonomic condition, as well as a therapuetic method for treating a dysautonomic disorder or dysautonomic condition by administration of, e.g., secretin, neuropeptides, peptides and/or digestive enzymes.
SUMMARY OF THE INVENTION.
The present invention is directed to methods for aiding in the diagnosis of dysuatonomic disorders and dysautonomic conditions, and for treating individuals diagnosed as having dysautonomic disorders or dysautonomic conditions inlcuding, but not limited to, Familial Dystautonomia (FD) (or Riley-Day Syndrome), Guillaine-Barre Syndrome (GBS) (acute idiopathic polyneuorpathy), Parkinson's disease, fetal fatal insomnia (FFI), diabetic cardiovascular neuropathy, Hereditary Sensory and autonomic nueropathy type III (HSAN III), central autonomic disorders including Parkinson's and multiple system atrophy (Shy-Drager syndrome), orthostatic intolerance syndrome including mitral value prolapse, postural tachycardia syndrome (POTS), and idiopathic hypovolemia, dysautonomic syndromes and disorders of the catecholemine family including baroreflex failure, dopamine-B-Hydroxylase deficiency, pheochromocytoma, chemodectina, familial paraganglioma syndrome, tetrahydrobiopterin deficiency, aromatic-L-amino acid decarboxylase deficiency, Menke's disease, monoamine oxidase deficiency states, and other disorders of dopamine metabolism, dysautonomic syndromes and disorders of the cardiovasular system, Chaga's disease, Diabetic autonomc failure, pure autonomic failure, syncope, hypertension, cardiovascular disease, renal disease and SIDS.
In one aspect, methods are provided for treating all types of dysautonomia and disorders with autonomic components by the admininsration of secretin, CCK(Choleystichenin), VIP (Vasoactive Intesinal Peptide), other neuropepetides and peptides, and/or digestive enzymes.
In another aspect, diagnostic methods are provided for determining whether an indivudual has, or can develop, a dysautonomic disorder or condition, and for determining whether an individual will benefit from the adminstration of secretin, CCK, VIP, other neurpeptides and peptides, and/or digestive enzymes for treating a dysautonomic disorder or condition. A preferred diagnostic method comprises analyzing a compound in a stool sample of an individual, and correlating the analysis of the compound with a dysautonomic disorder or condition or lack thereof. In one embodiment, the stool compound comprises a pancreatic enzyme such as chymotrypsin, or any compound that provides an indication of either protien digestion or metabolism, pancreatic function, or an inflammatory process, or a combination thereof. Preferably, the step of analyzing comprises determining a quantitative level of the compound in the stool.
In another aspect, a method for treating a dyautonomic disorder with secretin comprises the step of administering to an individual having the disorder an effective amount of secretin to improve a symptom of the disorder.
In yet another aspect, a method for treating a dysautonomic disorder with secretin comprises the steps of analyzing a compound in a stool sample of the individual, wherein the administration of secretin is based on the analysis of the stool sample.
In another aspect, the stool compound comprises a pancreatic enzyme such as chymotrypsin, or any compound that provides an indication of either protien digestion or metabolism, pancreatic function, or an inflammatory process, or a combination thereof.
In yet another aspect, a process of analyzing the stool sample comprises the steps of measuring a quantitative level of a pancreatic enzyme (such as chymotrypsin) present in the stool sample, and comparing the measured quantitative level with at least one threshold level to determine the efficacy of secretin administration to the individual. In one embodiment, the threshold level is based on a level of the pancreatic enzyme associated with at least one other individual of the same approximate age that does not have the dysautonomic disorder.
These and other aspects, features, and advantages of the present invention will be described and become apparent from the following detailed description of preferred embodiments, which is to be read with the accompanying drawings.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The present invention is directed to methods for aiding in the diagnosis of dysuatonomic disorders and dysautonomic conditions, and for treating individuals diagnosed as having a dysautonomic disorder such as Familial Dystautonomia and other disorders having dysautonomic components. In a preferred embodiment, a method is provided for determining the presence of abnormal protein digestion and/or pancreatic dysfunction of an individual, especially a child, by analyzing a stool sample of the individual for the quanititave levels of one or more pancreatic enzymes, including, but not limited to, chymotrypsin, so as to determine if the individual has, or can develop, a dysautonomic disorder or condition. Further, a method is provided for determining whether the individual is likely to benefit from the administration of secretin, CCK, VIP, digestive enzymes, and/or other peptides and/or neuropeptides. Until now, there has been no clear biological marker for dysautonic disorders or conditions to allow early diagnosis or screening of such disorders or conditions.
As noted above, it was recently discovered that the administration of secretin, a gastrointestinal peptide hormone, to children diagnosed with Autism resulted in ameliorating the symptoms associated with Autism. Subsequently, the inventor herein discovered that a sub-population of autistic children had, e.g., abnormal to pathologic levels of a pancreatic enzyme such as chymotrypsin in their stools. The inventor herein further discovered that the sub-population of autistic children who had low levels of fecal chymotryypsin were positive responders to therapeutic method for treating autism comprising administration of, e.g., secretin and/or digestive enzymes. It was further discovered that a sub-population of individuals suffering from ADD (attention deficit disorder) and/or ADHD (attention deficit hyperactivity disorder) who had low levels of fecal chymotryypsin were positive responders to therapeutic method comprising administration of, e.g., secretin and/or digestive enzymes. These findings are described in detail in U.S. patent application Ser. No. 09/466,559, filed Dec. 17, 1999, entitled "Methods For Treating Pervasive Development Disorders," and U.S. Ser. No. 09/707,395, filed on Nov. 7, 2000, entitled "Methods For Treating Pervasive Development Disorders", both of which are commonly owned and incorporated herein by reference.
It has also been discovered by the present inventor that populations of autistic children suffer from GI disturbances and other conditions which are dysautonomic in nature. Moreover, as explained below, and in accordance with the present invention, it has been discovered by the inventor herein that a population of individuals suffering from dysautonomic disorders such as FD and Parkinson's have abnormal or pathologic levels of pancreatic enzymes such as chymotrypsin in their stools. Thus, these findings are believed to indicate a possible link between the etiology of autism, ADD, ADHD and autonomic dysfunction. For example, it is postulated that in dysautonomic syndromes, the partial paresis of the gastrointestinal tract, and therefore the lack of functioning of the secretory cells of the proximal small intestine, preclude the proper formation and or release of secretin. It is further postulated that this abnormal protein digestion as reflected by the low levels of pancreatic enzymes such as chymotrypsin, can be improved by the administration of secretin, CCK, VIP, other neuropeptides, peptides and/or digestive enzymes to thereby ameliorate the symptomotologies of dysautonomic conditions. Indeed, as low measures of fecal chymotrypsin, for example, expresses an abnormality of protein digestion and/or pancreatic dysfunction, it is postulated that an improvement of protein digestion to promote normal growth and development of an individual suffering from a dysautonomic disorder or dysautonomic condition by the administration of secretin, CCK, VIP, other neuropeptides and/or peptides and/or digestive enzymes, can ameliorate the dysautonomic symptomatologies.
Claim 1 of 5 Claims
What is claimed is:
1. A method for treating Familial Dysautonomia with secretin, the method comprising the steps of:
comparing a fecal chymotrypsin level of the individual with a threshold fecal chymotrypsin level; and
administering secretin to the individual if the fecal chymotrypsin level of the individual is below the threshold fecal chymotrypsin level.