Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

Status unconfirmed · Phase 2

Conditions studied: Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases, Signs and Symptoms, Digestive

In brief

The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in children with autism.

Key facts

Study ID

NCT00110708

Run by

PediaMed Pharmaceuticals

People needed

120

Starts

2005-04-01

Expected to finish

2006-06-01

Last updated by the study team

2006-02-22

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female from 2 years to 18 years of age (up to, but not inclusive of the 18th birthday)
• 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)

You may not qualify if…

• Evidence of a gastrointestinal infection or GI abnormality
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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