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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by PediaMed Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Information provided by:
PediaMed Pharmaceuticals Identifier:
First received: May 12, 2005
Last updated: February 20, 2006
Last verified: February 2006
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
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
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

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00110708

  Show 22 Study Locations
Sponsors and Collaborators
PediaMed Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00110708     History of Changes
Other Study ID Numbers: Protocol 004
Study First Received: May 12, 2005
Last Updated: February 20, 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 processed this record on April 28, 2017