Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
NCT ID: NCT00110708
Last Updated: 2006-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2005-04-30
2006-06-30
Brief Summary
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Detailed Description
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The objective of this study is to assess the potential efficacy of oral immunoglobulin in reducing a wide range of GI symptoms in children and adolescents diagnosed with autistic disorder.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Oralgam (human immunoglobulin)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of autistic disorder corroborated by an Autism Diagnostic Interview - Revised (ADI-R) assessment performed by a certified investigator
* Physician Clinical Global Impression of Severity (of Autistic Disorder)
* History of chronic, persistent gastrointestinal disturbance
* No elective changes in medication, diet intervention, or behavioral therapy during the study (18 weeks total)
Exclusion Criteria
* A known diagnosis of other gastrointestinal pathology
* Antibiotic and/or antifungal (e.g. nystatin) medication
* Chelation therapy
* Medication affecting gastrointestinal transit
* Planned use of prohibited drugs or agents that could affect GI transit
* Changes in diet intervention within 30 days prior to the screening visit
* Changes in alternative medical therapies or dietary supplements within 30 days prior to the screening visit
* Adding and/or changing behavior modification or psychotherapy during participation in the study
* Adding or changing psychotropic medication during participation in the study
* DSM-IV diagnosis of a pervasive developmental disorder other than autistic disorder
* Evidence of a seizure disorder, diagnosis of fragile X syndrome, tuberous sclerosis complex, liver disease, pancreatic disease, cystic fibrosis, or chronic infection
* Previous gastrointestinal surgery
* Pregnancy
* Participation in another investigational study
* Significant deviation from normal laboratory test values at baseline
* IgA deficiency (serum IgA \< 5 mg/dL)
* A history of severe hypersensitivity to human immunoglobulin
* Treatment with any human immunoglobulin and/or immunoglobulin products
* Any concurrent medication that would compromise subject's tolerance of drug or compliance with the protocol
2 Years
18 Years
ALL
No
Sponsors
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PediaMed Pharmaceuticals
INDUSTRY
Locations
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Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
Center for Autism Research and Education
Phoenix, Arizona, United States
University of California Davis, MIND Institute
Sacramento, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
University of Florida HSC
Gainesville, Florida, United States
International Child Development Resource Center
Melbourne, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kansas Medical Center, Developmental Disabilities Center
Kansas City, Kansas, United States
Bluegrass Clinical Research
Louisville, Kentucky, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
Hardy Health Associates
Hingham, Massachusetts, United States
Pivotal Research Centers - Detroit
Royal Oak, Michigan, United States
Mercy Health Research
St Louis, Missouri, United States
Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Strong Center for Developmental Disabilities, University of Rochester Medical Center
Rochester, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nisonger Center Ohio State University
Columbus, Ohio, United States
Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, United States
North San Antonio Healthcare Associates
San Antonio, Texas, United States
Autism Spectrum Treatment and Research Center
Seattle, Washington, United States
Countries
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References
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Handen BL, Melmed RD, Hansen RL, Aman MG, Burnham DL, Bruss JB, McDougle CJ. A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder. J Autism Dev Disord. 2009 May;39(5):796-805. doi: 10.1007/s10803-008-0687-y. Epub 2009 Jan 16.
Other Identifiers
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Protocol 004
Identifier Type: -
Identifier Source: org_study_id