AutismPhase 2NCT00110708
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
A Phase 2 study testing Oralgam (human immunoglobulin) in people with Autism and Autistic Disorder, run by PediaMed Pharmaceuticals at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autism, Autistic Disorder, Child Development Disorders, Pervasive
- What is being tested?
- Oralgam (human immunoglobulin)
- How many people
- 120 participants
- Where
- 22 sitesUnited States
- Study dates
- Apr 2005to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039
Nisonger Center Ohio State University
Columbus, Ohio, 43210
Sarkis Clinical Trials
Gainesville, Florida, 32607
University of Florida HSC
Gainesville, Florida, 32608
Hardy Health Associates
Hingham, Massachusetts, 02043
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Kansas Medical Center, Developmental Disabilities Center
Kansas City, Kansas, 66160
Bluegrass Clinical Research
Louisville, Kentucky, 40291
International Child Development Resource Center
Melbourne, Florida, 32901
Medical Research Group of Central Florida
Orange City, Florida, 32763
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
Center for Autism Research and Education
Phoenix, Arizona, 85012
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, 15203
Strong Center for Developmental Disabilities, University of Rochester Medical Center
Rochester, New York, 14642
Pivotal Research Centers - Detroit
Royal Oak, Michigan, 48073
University of California Davis, MIND Institute
Sacramento, California, 95817
North San Antonio Healthcare Associates
San Antonio, Texas, 78217
Autism Spectrum Treatment and Research Center
Seattle, Washington, 98109
Mercy Health Research
St Louis, Missouri, 63141
About this study
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
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.
Read the 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.
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases, Signs and Symptoms, Digestive
- Being tested
- Oralgam (human immunoglobulin)
- Keywords
- 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
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases, Signs and Symptoms, Digestive, Diarrhea, Constipation, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oralgam (human immunoglobulin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Global improvement in gastrointestinal function
Secondary outcomes (1)
Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2005 (estimated)
- Study startApr 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- PediaMed Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110708
- Sponsor's protocol ID
- Protocol 004
- Status last verified
- Feb 2006
- First submitted
- 12 May 2005
- Last updated
- 22 Feb 2006
- Results posted
- No
Publications
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.
PubMed 19148734
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00110708
- Acronym / sponsor ID
- Protocol 004
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases, Signs and Symptoms, Digestive
- Keywords
- autism, gastrointestinal dysfunction, autistic disorder, diarrhea, constipation, abdominal pain, gastrointestinal problems associated with autism, immune globulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- PediaMed PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jun 2006
- First posted
- 13 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oralgam (human immunoglobulin) | Drug | – |
Primary outcome
Global improvement in gastrointestinal function
1 secondary outcome
Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
- Derived from this study: PubMed 19148734Handen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oralgam (human immunoglobulin) in people with Autism and Autistic Disorder, run by PediaMed Pharmaceuticals at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global improvement in gastrointestinal function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2006.