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

February 20, 2006 updated by: PediaMed Pharmaceuticals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Global improvement in gastrointestinal function

Secondary Outcome Measures

Outcome Measure
Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PediaMed Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

May 12, 2005

First Submitted That Met QC Criteria

May 12, 2005

First Posted (Estimate)

May 13, 2005

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 20, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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