Status:
UNKNOWN
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
Lead Sponsor:
PediaMed Pharmaceuticals
Conditions:
Autism
Autistic Disorder
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
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, abdo...
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 diarrhe...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00110708
Start Date
April 1 2005
End Date
June 1 2006
Last Update
February 22 2006
Active Locations (22)
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1
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
2
Center for Autism Research and Education
Phoenix, Arizona, United States, 85012
3
University of California Davis, MIND Institute
Sacramento, California, United States, 95817
4
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607