Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions

• US 10,209,253 B2
• Filed: 05/25/2016
• Issued: 02/19/2019
• Est. Priority Date: 11/16/2000
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M.
• Primary Examiner(s): Navarro, Albert M
• Application Number:
  US15/164,493
• Publication Number:
  US 20160266113A1
• Time in Patent Office: 1,000 Days
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/689 for bacteria
• CPC Class Codes: C12Q 1/6893 for protozoa
• CPC Class Codes: C12Q 1/6895 for plants, fungi or algae
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• CPC Class Codes: G01N 2800/28 Neurological disorders
• CPC Class Codes: G01N 2800/2835 Movement disorders, e.g. Parkinson, Huntington, Tourette
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G01N 33/56905 Protozoa
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Methods for aiding in the diagnosis of disorders including, but not limited to, PDDs (Pervasive Development Disorders), Dysautonomic disorders, Parkinson'"'"'s disease and SIDS (Sudden Infant Death Syndrome). In one aspect, a diagnosis method comprises analyzing a stool sample of an individual for the presence of a biological marker (or marker compound) comprising one or more pathogens, which provides an indication of whether the individual has, or can develop, a disorder including, but not limited to, a PDD, Dysautonomia, Parkinsons disease and SIDS. Preferably, the presence of one or more pathogens is determined using a stool immunoassay to determine the presence of antigens in a stool sample, wherein such antigens are associated with one or more pathogens including, but not limited to, Giardia, Cryptosporidium, E. histolytica, C. difficile, Adenovirus, Rotavirus or H. pylori.

Claims

1. A method for determining if an individual has, or can develop, a Pervasive Development Disorder (PDD), comprising the steps of:

detecting a level of chymotrypsin in a stool sample obtained from the individual;

analyzing the stool sample obtained from the individual with a stool immunoassay to determine the presence or absence of one or more antigens associated with a Clostridium difficile, and to determine the presence or absence of one or more antigens associated with one or more pathogens selected from the group consisting of a Helicobacter pylori, an Entamoeba histolytica, and a combination thereof;

detecting whether the one or more one or more antigens associated with the Clostridium difficile is present in the stool sample, and detecting whether one or more antigens associated with one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is present in the stool sample; and

determining that the individual has, or can develop, a PDD when the presence of one or more antigens associated with Clostridium difficile is detected, and when the presence of one or more antigens associated with the one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is detected.

2. The method of claim 1, wherein the PDD comprises Autism.

3. The method of claim 2, wherein determining if the individual has, or can develop, Autism further comprises a CARS or an ADOS test.

4. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with a Giardia in the stool sample.

5. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with a Rotavirus in the stool sample.

6. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with an Adenovirus in the stool sample.

7. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with a Cyclospora in the stool sample.

8. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with a Microsporidia in the stool sample.

9. The method of claim 1, further comprising determining the presence or absence of one or more antigens associated with an Isospora belli in the stool sample.

10. The method of claim 1, wherein the method detects the Clostridium difficile and the Entamoeba histolytica.

11. The method of claim 1, wherein the method detects the Clostridium difficile and the Helicobacter pylori.

12. The method of claim 1, wherein the method detects the Clostridium difficile, the Entamoeba histolytica, and the Helicobacter pylori.

13. The method of claim 1, further comprising administering to the individual a pharmaceutical composition that comprises digestive enzymes.

14. A method for determining if an individual has, or can develop, a Pervasive Development Disorder (PDD), comprising the steps of:

analyzing a stool sample obtained from the individual with a stool immunoassay to determine the presence or absence of one or more antigens associated with a Clostridium difficile, and to determine the presence or absence of one or more antigens associated with one or more pathogens selected from the group consisting of a Helicobacter pylori, an Entamoeba histolytica, and a combination thereof;

detecting whether the one or more one or more antigens associated with the Clostridium difficile is present in the stool sample, and detecting whether one or more antigens associated with one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is present in the stool sample;

determining that the individual has, or can develop, a PDD when the presence of one or more antigens associated with Clostridium difficile is detected, and when the presence of one or more antigens associated with the one or more pathogens selected from the group consisting of the Helicobacter pylori, the Entamoeba histolytica, and a combination thereof is detected; and

administering to the individual a pharmaceutical composition that comprises digestive enzymes.

15. The method of claim 14, further comprising detecting a level of chymotrypsin in the stool sample.

16. The method of claim 14, wherein the PDD comprises Autism.

17. The method of claim 16, wherein determining if the individual has, or can develop, Autism further comprises a CARS or an ADOS test.

18. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with a Giardia in the stool sample.

19. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with a Rotavirus in the stool sample.

20. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with an Adenovirus in the stool sample.

21. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with a Cyclospora in the stool sample.

22. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with a Microsporidia in the stool sample.

23. The method of claim 14, further comprising determining the presence or absence of one or more antigens associated with an Isospora belli in the stool sample.

24. The method of claim 14, wherein the method detects the Clostridium difficile and the Entamoeba histolytica.

25. The method of claim 14, wherein the method detects the Clostridium difficile and the Helicobacter pylori.

26. The method of claim 14, wherein the method detects the Clostridium difficile, the Entamoeba histolytica, and the Helicobacter pylori.