Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
- Conditions
- AutismAutistic DisorderChild Development Disorders, PervasiveGastrointestinal DiseasesSigns and Symptoms, Digestive
- Registration Number
- NCT00110708
- Lead Sponsor
- PediaMed Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Autistic GI Dysfunction (AGID) is a term that describes a constellation of GI signs and symptoms often found in children with autistic disorder, including abdominal pain, constipation, chronic diarrhea, alternating constipation and diarrhea, gaseousness, bloating, and reflux.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Global improvement in gastrointestinal function
- Secondary Outcome Measures
Name Time Method Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Trial Locations
- Locations (22)
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
North San Antonio Healthcare Associates
🇺🇸San Antonio, Texas, United States
University of Kansas Medical Center, Developmental Disabilities Center
🇺🇸Kansas City, Kansas, United States
Gulf Coast Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Robert Wood Johnson Medical School
🇺🇸Piscataway, New Jersey, United States
Center for Autism Research and Education
🇺🇸Phoenix, Arizona, United States
Southwest Autism Research and Resource Center
🇺🇸Phoenix, Arizona, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Hardy Health Associates
🇺🇸Hingham, Massachusetts, United States
Mercy Health Research
🇺🇸St. Louis, Missouri, United States
University of Florida HSC
🇺🇸Gainesville, Florida, United States
International Child Development Resource Center
🇺🇸Melbourne, Florida, United States
Pivotal Research Centers - Detroit
🇺🇸Royal Oak, Michigan, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Bluegrass Clinical Research
🇺🇸Louisville, Kentucky, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
University of California Davis, MIND Institute
🇺🇸Sacramento, California, United States
Strong Center for Developmental Disabilities, University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Nisonger Center Ohio State University
🇺🇸Columbus, Ohio, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Merck Child Outpatient Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Autism Spectrum Treatment and Research Center
🇺🇸Seattle, Washington, United States