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The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.
Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM-AT | Experimental | Active substance in single unit dose powder |
|
| Placebo | Placebo Comparator | Placebo powder of inactive substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM-AT | Drug | Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit | Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC. | Screening through Week 12/Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measurements of Changes in the Aberrant Behavior Checklist Checklist Subscale for Lethargy / Social Withdrawal (ABC-L) Between Baseline and Week 12/Termination Visit | Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Pearson, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Robert Hendren, DO | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research & Resource Center (S.A.R.R.C.) | Phoenix | Arizona | 85006 | United States | ||
| University of Arizona, Pediatrics Multidisciplinary Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21464191 | Background | McPheeters ML, Warren Z, Sathe N, Bruzek JL, Krishnaswami S, Jerome RN, Veenstra-Vanderweele J. A systematic review of medical treatments for children with autism spectrum disorders. Pediatrics. 2011 May;127(5):e1312-21. doi: 10.1542/peds.2011-0427. Epub 2011 Apr 4. | |
| Background | Baio, J. Prevalence of Autism Spectrum Disorders - Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States. (2008), Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6103a1.htm?s_cid=ss6103a1_w. | ||
| Background | Baio, J. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States. (2010). Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6302a1.htm?s_cid=ss6302a1_w. | ||
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Participants were screened for autistic disorder using the Diagnostic Statistical Manual of Mental Disorders Fourth Edition - Text Revised (DSM-IV-TR); and the Social Communication Questionnaire (SCQ), with diagnostic confirmation by the Autism Diagnostic Interview-Revised (ADI-R). All qualifying participants were given a 2 week run-in period and then reassessed for eligibility and then randomized.
Participants were recruited across 33 sites in the USA. The First Subject First Visit (FSFV) occurred on 03 June 2015 (First screening visit date) and the Last Subject Last Visit (LSLV) occurred on 20 December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | CM-AT | Active substance in single unit dose powder CM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | May 3, 2021 |
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| PLACEBO | Drug | Single unit dose powder of non-active substance administered 3 times per day for 90 days |
|
|
| Screening through Week 12/Termination. |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Arkansas Children'S Hosp. Research Institute (A.C.H.R.I.) | Little Rock | Arkansas | 72202 | United States |
| N.R.C. Research Institute | Orange | California | 92868 | United States |
| M.I.N.D. Institute (Univ.of California, Davis) | Sacramento | California | 95817 | United States |
| University of California (U.C.S.F.) | San Francisco | California | 94143-0984 | United States |
| IMMUNOe RESEARCH CENTERS | Centennial | Colorado | 80112 | United States |
| Yale Child Study Center | New Haven | Connecticut | 06519 | United States |
| Segal Institute For Clinical Research | North Miami | Florida | 33161 | United States |
| Florida Hospital Medical Group-Lake Mary Pediatrics | Orange City | Florida | 32763 | United States |
| Kaley Kildahl | Orlando | Florida | 32803 | United States |
| Research Institute of Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| L.S.U. Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Detroit Clinical Research Center, P.C. | Bingham Farms | Michigan | 48025 | United States |
| Children'S Specialized Hospital | Egg Harbor | New Jersey | 08234 | United States |
| Children'S Specialized Hospital | Toms River | New Jersey | 08755 | United States |
| Clinical Research Center of Nj | Voorhees Township | New Jersey | 08043 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Montefiore Med.Center, Autism & Obsessive Compulsive Spectrum Prog. | The Bronx | New York | 10467 | United States |
| Duke Center For Autism and Brain Development | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic, Center For Autism Research | Cleveland | Ohio | 44104 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| Vanderbilt University Med.Center -Treatment & Research Inst. For Asd | Nashville | Tennessee | 37232-2551 | United States |
| University of Texas, Houston Dept. of Psychiatry and Behavioral Sciences | Houston | Texas | 77054 | United States |
| Ericksen Research & Development | Clinton | Utah | 84015 | United States |
| University of Virginia, Dept. of Psychiatry and Neurobehavioral Sciences | Charlottesville | Virginia | 22903 | United States |
| Neuroscience, Inc. | Herndon | Virginia | 20170 | United States |
| Carilion Clinic-Virginia Tech, Carilion School of Medicine | Roanoke | Virginia | 24014 | United States |
| Background |
| Peacock G, Amendah D, Ouyang L, Grosse SD. Autism spectrum disorders and health care expenditures: the effects of co-occurring conditions. J Dev Behav Pediatr. 2012 Jan;33(1):2-8. doi: 10.1097/DBP.0b013e31823969de. |
| 17404130 | Background | Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343. |
| 24777214 | Background | McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995. |
| 20048083 | Background | Buie T, Campbell DB, Fuchs GJ 3rd, Furuta GT, Levy J, Vandewater J, Whitaker AH, Atkins D, Bauman ML, Beaudet AL, Carr EG, Gershon MD, Hyman SL, Jirapinyo P, Jyonouchi H, Kooros K, Kushak R, Levitt P, Levy SE, Lewis JD, Murray KF, Natowicz MR, Sabra A, Wershil BK, Weston SC, Zeltzer L, Winter H. Evaluation, diagnosis, and treatment of gastrointestinal disorders in individuals with ASDs: a consensus report. Pediatrics. 2010 Jan;125 Suppl 1:S1-18. doi: 10.1542/peds.2009-1878C. |
| 25110424 | Background | Samsam M, Ahangari R, Naser SA. Pathophysiology of autism spectrum disorders: revisiting gastrointestinal involvement and immune imbalance. World J Gastroenterol. 2014 Aug 7;20(29):9942-51. doi: 10.3748/wjg.v20.i29.9942. |
| 22495912 | Background | Elsabbagh M, Divan G, Koh YJ, Kim YS, Kauchali S, Marcin C, Montiel-Nava C, Patel V, Paula CS, Wang C, Yasamy MT, Fombonne E. Global prevalence of autism and other pervasive developmental disorders. Autism Res. 2012 Jun;5(3):160-79. doi: 10.1002/aur.239. Epub 2012 Apr 11. |
| 7559972 | Background | Wasfy M, Oyofo B, Elgindy A, Churilla A. Comparison of preservation media for storage of stool samples. J Clin Microbiol. 1995 Aug;33(8):2176-8. doi: 10.1128/jcm.33.8.2176-2178.1995. |
| 2734275 | Background | Cavallini G, Benini L, Brocco G, Riela A, Bovo P, Pederzoli P, Angelini G, Pelle C, Bertelli G, Scuro LA. The fecal chymotrypsin photometric assay in the evaluation of exocrine pancreatic capacity. Comparison with other direct and indirect pancreatic function tests. Pancreas. 1989;4(3):300-4. doi: 10.1097/00006676-198906000-00005. |
| 4563292 | Background | Matthews DM. Intestinal absorption of amino acids and peptides. Proc Nutr Soc. 1972 Sep;31(2):171-7. doi: 10.1079/pns19720033. No abstract available. |
| 15094787 | Background | Coutinho AM, Oliveira G, Morgadinho T, Fesel C, Macedo TR, Bento C, Marques C, Ataide A, Miguel T, Borges L, Vicente AM. Variants of the serotonin transporter gene (SLC6A4) significantly contribute to hyperserotonemia in autism. Mol Psychiatry. 2004 Mar;9(3):264-71. doi: 10.1038/sj.mp.4001409. |
| 24772971 | Background | Naushad SM, Jain JM, Prasad CK, Naik U, Akella RR. Autistic children exhibit distinct plasma amino acid profile. Indian J Biochem Biophys. 2013 Oct;50(5):474-8. |
| 25155956 | Background | Tang G, Gudsnuk K, Kuo SH, Cotrina ML, Rosoklija G, Sosunov A, Sonders MS, Kanter E, Castagna C, Yamamoto A, Yue Z, Arancio O, Peterson BS, Champagne F, Dwork AJ, Goldman J, Sulzer D. Loss of mTOR-dependent macroautophagy causes autistic-like synaptic pruning deficits. Neuron. 2014 Sep 3;83(5):1131-43. doi: 10.1016/j.neuron.2014.07.040. Epub 2014 Aug 21. |
| 23403946 | Background | Balasubramanian MN, Butterworth EA, Kilberg MS. Asparagine synthetase: regulation by cell stress and involvement in tumor biology. Am J Physiol Endocrinol Metab. 2013 Apr 15;304(8):E789-99. doi: 10.1152/ajpendo.00015.2013. Epub 2013 Feb 12. |
| 7192244 | Background | Fairclough PD, Hegarty JE, Silk DB, Clark ML. Comparison of the absorption of two protein hydrolysates and their effects on water and electrolyte movements in the human jejunum. Gut. 1980 Oct;21(10):829-34. doi: 10.1136/gut.21.10.829. |
| 12959424 | Background | Arnold GL, Hyman SL, Mooney RA, Kirby RS. Plasma amino acids profiles in children with autism: potential risk of nutritional deficiencies. J Autism Dev Disord. 2003 Aug;33(4):449-54. doi: 10.1023/a:1025071014191. |
| 20204691 | Background | Munasinghe SA, Oliff C, Finn J, Wray JA. Digestive enzyme supplementation for autism spectrum disorders: a double-blind randomized controlled trial. J Autism Dev Disord. 2010 Sep;40(9):1131-8. doi: 10.1007/s10803-010-0974-2. |
| 15449518 | Background | Schreck KA, Williams K, Smith AF. A comparison of eating behaviors between children with and without autism. J Autism Dev Disord. 2004 Aug;34(4):433-8. doi: 10.1023/b:jadd.0000037419.78531.86. |
| 18570292 | Background | Bailey DB Jr, Raspa M, Olmsted M, Holiday DB. Co-occurring conditions associated with FMR1 gene variations: findings from a national parent survey. Am J Med Genet A. 2008 Aug 15;146A(16):2060-9. doi: 10.1002/ajmg.a.32439. |
| 16283084 | Background | Lecavalier L. An evaluation of the Gilliam Autism Rating Scale. J Autism Dev Disord. 2005 Dec;35(6):795-805. doi: 10.1007/s10803-005-0025-6. |
| 19797985 | Background | Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658. |
| 19998356 | Background | Yerys BE, Wallace GL, Sokoloff JL, Shook DA, James JD, Kenworthy L. Attention deficit/hyperactivity disorder symptoms moderate cognition and behavior in children with autism spectrum disorders. Autism Res. 2009 Dec;2(6):322-33. doi: 10.1002/aur.103. |
| 16043324 | Background | Schreck KA, Williams K. Food preferences and factors influencing food selectivity for children with autism spectrum disorders. Res Dev Disabil. 2006 Jul-Aug;27(4):353-63. doi: 10.1016/j.ridd.2005.03.005. Epub 2005 Jul 25. |
| 16217179 | Background | Borowitz D. Update on the evaluation of pancreatic exocrine status in cystic fibrosis. Curr Opin Pulm Med. 2005 Nov;11(6):524-7. doi: 10.1097/01.mcp.0000181474.08058.b3. |
| 17304111 | Background | Penn AH, Hugli TE, Schmid-Schonbein GW. Pancreatic enzymes generate cytotoxic mediators in the intestine. Shock. 2007 Mar;27(3):296-304. doi: 10.1097/01.shk.0000235139.20775.7f. |
| 20687077 | Background | Williams K, Wheeler DM, Silove N, Hazell P. Selective serotonin reuptake inhibitors (SSRIs) for autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2010 Aug 4;(8):CD004677. doi: 10.1002/14651858.CD004677.pub2. |
| 38032645 | Derived | Pearson DA, Hendren RL, Heil MF, McIntyre WR, Raines SR. Pancreatic Replacement Therapy for Maladaptive Behaviors in Preschool Children With Autism Spectrum Disorder. JAMA Netw Open. 2023 Nov 1;6(11):e2344136. doi: 10.1001/jamanetworkopen.2023.44136. |
Placebo powder of inactive substance PLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. |
| Randomized |
|
| ITT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CM-AT | Active substance in single unit dose powder CM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. |
| BG001 | Placebo | Placebo powder of inactive substance PLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| ABC-I | The ABC-I is a discrete sub scale of the Aberrant Behavior Checklist (ABC) - Community. The "I" is the Irritability sub scale. Scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). The Baseline measurement indicates the subject's initial score on this sub scale. Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on scale (0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree). Questions correspond to one of 5 sub scales. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit | Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC. | Posted | Mean | Standard Deviation | units on a scale | Screening through Week 12/Termination |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Outcome Measurements of Changes in the Aberrant Behavior Checklist Checklist Subscale for Lethargy / Social Withdrawal (ABC-L) Between Baseline and Week 12/Termination Visit | Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. | Posted | Mean | Standard Deviation | units on a scale | Screening through Week 12/Termination. |
|
Adverse Events were recorded from the time of consent through 30-days following subject completion of or withdrawal from study, equalling a maximum of 128 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CM-AT | Active substance in single unit dose powder CM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. | 0 | 92 | 0 | 92 | 79 | 92 |
| EG001 | Placebo | Placebo powder of inactive substance PLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. | 0 | 98 | 0 | 98 | 90 | 98 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Stool pH Decreased | Investigations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Stool Analysis Abnormal | Investigations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Clostridium Test Positive | Investigations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Stool pH Increased | Investigations | MedDRA Version 18 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 18 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18 | Non-systematic Assessment |
|
Publications include input from PI and Curemark reflected in authorship. Institution's results may be submitted after results of the multicenter study are published, 18m after completion, or if multicenter publication isn't planned. Then PI may to publish, subject to confidentiality agreement. PI shall give to Curemark 45 days prior for review. Submission of such publication of results be can't delayed more than 105d after being received by Curemark. After 105 days, the PI may publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William E. Gannon, Jr MD, Medical Director | Curemark | 914-824-9716 | william.gannon@curemark.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 27, 2017 | May 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|