Autism Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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