Autism Trial with Digestive Enzyme CM-AT

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Summary

  • Study director: Robert Hendren, DO
  • Sponsor: Curemark, LLC
  • Recruiting?: Yes
  • Official study title: An Open-Label Extension Study of LUMINENZ-ATâ„¢ (CM-AT) in Children with Autism
  • ClinicalTrials.gov identifier: NCT00881452
  • Conditions studied: Autistic disorder
  • Intervention: CM-AT (pancreatic enzyme) is a pancreatic enzyme and is sprinkled onto food three times daily.
  • Phase: Phase III
  • Purpose: It is hoped that CM-AT will help improve autistic symptoms through a positive impact on gastrointestinal function.

Eligibility

  • Inclusion criteria:
    • Child is 9–12 years old
    • Child has a diagnosis of autistic disorder
    • Child must have a low fecal chymotrypsin level (we will measure)
  • Exclusion criteria:
    • Child must have no dietary restrictions (other than for a nut allergy)
    • Child may not have an allergy to pork products
    • Child may not have a history of severe head trauma or stroke
    • Child may not have had a seizure within the past year
    • Child may not be diagnosed with: HIV, cerebral palsy, endocrine disorder or pancreatic disease
    • Child may not be taking any enzyme product, amino acids, secretin product or stimulant medication currently

What is involved?

  • Testing: Behavioral assessments, cognitive testing, parent questionnaires, physical examinations, stool specimen collection, and vital signs
  • Frequency of visits: The initial study will last twelve weeks, and will involve seven visits to UCSF, each visit about two to four weeks apart. After completion of the initial study you and your child will have the option to continue for another 72 weeks (about a year and a half). This portion of the study will have ten visits, every four to twelve weeks.
  • Materials needed prior to evaluation: None
  • Costs: No costs will be charged for any of the study procedures. We will provide $40 at each visit, to help with costs of transportation and parking.

Contact information