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

• Status: Unknown status
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PediaMed Pharmaceuticals
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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