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.

Condition	Treatment or Intervention	Phase
Autism Autistic Disorder Child Development Disorders, Pervasive Gastrointestinal Diseases Signs and Symptoms, Digestive	Drug: Oralgam (human immunoglobulin)	Phase II

Further Study Details: 

Primary Outcomes: Global improvement in gastrointestinal function
Secondary Outcomes: Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  2 Years   -   18 Years,  Genders Eligible for Study:  Both

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
• Psychotropic medication
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00110708

PediaMed Pharmaceuticals       autism@pediamedpharma.com

Arizona
      Southwest Autism Research and Resource Center, Phoenix,  Arizona,  85006,  United States; Recruiting
Florida
      Sarkis Clinical Trials, Gainesville,  Florida,  32607,  United States; Recruiting
      University of Florida HSC, Gainesville,  Florida,  32608,  United States; Recruiting
Indiana
      Riley Hospital for Children, Indianapolis,  Indiana,  46202,  United States; Not yet recruiting
Massachusetts
      Hardy Health Associates, Hingham,  Massachusetts,  02043,  United States; Recruiting
New Jersey
      Robert Wood Johnson Medical School, Piscataway,  New Jersey,  08854,  United States; Not yet recruiting
Ohio
      Nisonger Center Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
      Pediatric Clinical Trials, Inc, Akron,  Ohio,  44308,  United States; Recruiting
      Cincinnati Children's Hospital, Cincinnati,  Ohio,  45229-3039,  United States; Not yet recruiting
Pennsylvania
      Merck Child Outpatient Clinic, Pittsburgh,  Pennsylvania,  15203,  United States; Recruiting
Washington
      Autism Spectrum Treatment and Research Center, Seattle,  Washington,  98109,  United States; Recruiting
      Sacred Heart Medical Center Clinical Research Center, Spokane,  Washington,  99204,  United States; Recruiting

Study ID Numbers:  Protocol 004
Record last reviewed:  May 2005
Last Updated:  May 12, 2005
Record first received:  May 12, 2005
ClinicalTrials.gov Identifier:  NCT00110708
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17