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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by PediaMed Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
PediaMed Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00110708
First received: May 12, 2005
Last updated: February 20, 2006
Last verified: February 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by PediaMed Pharmaceuticals:

Primary Outcome Measures:
  • Global improvement in gastrointestinal function

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

Estimated Enrollment: 120
Study Start Date: April 2005
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110708

  Hide Study Locations
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
  More Information

No publications provided by PediaMed Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00110708     History of Changes
Other Study ID Numbers: Protocol 004
Study First Received: May 12, 2005
Last Updated: February 20, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by PediaMed Pharmaceuticals:
autism
gastrointestinal dysfunction
autistic disorder
diarrhea
constipation
abdominal pain
gastrointestinal problems associated with autism
immune globulin
immunoglobulin
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
Developmental Disabilities
Child Development Disorders, Pervasive
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Gastrointestinal Agents
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014