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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : June 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Global improvement in gastrointestinal function

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

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00110708


  Show 22 Study Locations
Sponsors and Collaborators
PediaMed Pharmaceuticals
More Information

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
First Posted: May 13, 2005    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: February 2006

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:
Disease
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
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs