Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
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
1 other identifier
interventional
120
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 12, 2005
CompletedFirst Posted
Study publicly available on registry
May 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFebruary 22, 2006
February 1, 2006
May 12, 2005
February 20, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global improvement in gastrointestinal function
Secondary Outcomes (1)
Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006, United States
Center for Autism Research and Education
Phoenix, Arizona, 85012, United States
University of California Davis, MIND Institute
Sacramento, California, 95817, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
University of Florida HSC
Gainesville, Florida, 32608, United States
International Child Development Resource Center
Melbourne, Florida, 32901, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center, Developmental Disabilities Center
Kansas City, Kansas, 66160, United States
Bluegrass Clinical Research
Louisville, Kentucky, 40291, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
Hardy Health Associates
Hingham, Massachusetts, 02043, United States
Pivotal Research Centers - Detroit
Royal Oak, Michigan, 48073, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854, United States
Strong Center for Developmental Disabilities, University of Rochester Medical Center
Rochester, New York, 14642, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039, United States
Nisonger Center Ohio State University
Columbus, Ohio, 43210, United States
Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, 15203, United States
North San Antonio Healthcare Associates
San Antonio, Texas, 78217, United States
Autism Spectrum Treatment and Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
Handen BL, Melmed RD, Hansen RL, Aman MG, Burnham DL, Bruss JB, McDougle CJ. A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder. J Autism Dev Disord. 2009 May;39(5):796-805. doi: 10.1007/s10803-008-0687-y. Epub 2009 Jan 16.
PMID: 19148734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2005
First Posted
May 13, 2005
Study Start
April 1, 2005
Study Completion
June 1, 2006
Last Updated
February 22, 2006
Record last verified: 2006-02