Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
Recruitment status was Active, not recruiting
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.
Child Development Disorders, Pervasive
Signs and Symptoms, Digestive
Drug: Oralgam (human immunoglobulin)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- Global improvement in gastrointestinal function
- Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||June 2006|
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.
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