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

PediaMed Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Autistic Disorder

Signs and Symptoms, Digestive

Gastrointestinal Diseases

Child Development Disorders, Pervasive

Autism

Treatments

Drug: Oralgam (human immunoglobulin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110708

Protocol 004

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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