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

Autism Clinical Trial

Official title:

A Randomized, Placebo-Controlled Phase II Trial Evaluating Safety and Efficacy of Oral Human Immunoglobulin in the Treatment of Gastrointestinal Dysfunction Associated With Autistic Disorder in Pediatric Patients From 2 to 18 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00110708
• Other study ID #: Protocol 004
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 12, 2005
• Last updated: February 20, 2006
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: February 2006
• Source: PediaMed Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Digestive System Diseases
• Disease
• Gastrointestinal Diseases
• Signs and Symptoms
• Signs and Symptoms, Digestive

Intervention

Drug:
• Oralgam (human immunoglobulin)

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Nisonger Center Ohio State University	Columbus	Ohio
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	University of Florida HSC	Gainesville	Florida
United States	Hardy Health Associates	Hingham	Massachusetts
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	International Child Development Resource Center	Melbourne	Florida
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Center for Autism Research and Education	Phoenix	Arizona
United States	Southwest Autism Research and Resource Center	Phoenix	Arizona
United States	Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	Merck Child Outpatient Clinic	Pittsburgh	Pennsylvania
United States	Strong Center for Developmental Disabilities, University of Rochester Medical Center	Rochester	New York
United States	Pivotal Research Centers – Detroit	Royal Oak	Michigan
United States	University of California Davis, MIND Institute	Sacramento	California
United States	North San Antonio Healthcare Associates	San Antonio	Texas
United States	Autism Spectrum Treatment and Research Center	Seattle	Washington
United States	Mercy Health Research	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
PediaMed Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global improvement in gastrointestinal function
Secondary	Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions