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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110708
Recruitment Status : Unknown
Verified February 2006 by PediaMed Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2005
Last Update Posted : February 22, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autism Autistic Disorder Child Development Disorders, Pervasive Gastrointestinal Diseases Signs and Symptoms, Digestive Drug: Oralgam (human immunoglobulin) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : April 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Global improvement in gastrointestinal function

Secondary Outcome Measures :
  1. Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110708

  Hide Study Locations
United States, Arizona
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
Center for Autism Research and Education
Phoenix, Arizona, United States, 85012
United States, California
University of California Davis, MIND Institute
Sacramento, California, United States, 95817
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
University of Florida HSC
Gainesville, Florida, United States, 32608
International Child Development Resource Center
Melbourne, Florida, United States, 32901
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center, Developmental Disabilities Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Bluegrass Clinical Research
Louisville, Kentucky, United States, 40291
United States, Louisiana
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Hardy Health Associates
Hingham, Massachusetts, United States, 02043
United States, Michigan
Pivotal Research Centers – Detroit
Royal Oak, Michigan, United States, 48073
United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New Jersey
Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
United States, New York
Strong Center for Developmental Disabilities, University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229-3039
Nisonger Center Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, United States, 15203
United States, Texas
North San Antonio Healthcare Associates
San Antonio, Texas, United States, 78217
United States, Washington
Autism Spectrum Treatment and Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
PediaMed Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00110708     History of Changes
Other Study ID Numbers: Protocol 004
First Posted: May 13, 2005    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: February 2006

Keywords provided by PediaMed Pharmaceuticals:
gastrointestinal dysfunction
autistic disorder
abdominal pain
gastrointestinal problems associated with autism
immune globulin
Immunoglobulins, Intravenous
Intestinal Mucosa/immunology/pathology
Administration, Oral
Autistic Disorder/*drug therapy
Child Behavior/*drug effects
Constipation/drug therapy
Diarrhea/drug therapy
Gastrointestinal Agents/*therapeutic use

Additional relevant MeSH terms:
Autistic Disorder
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Developmental Disabilities
Signs and Symptoms, Digestive
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs