Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
|ClinicalTrials.gov Identifier: NCT00110708|
Recruitment Status : Unknown
Verified February 2006 by PediaMed Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : May 13, 2005
Last Update Posted : February 22, 2006
|Condition or disease||Intervention/treatment||Phase|
|Autism Autistic Disorder Child Development Disorders, Pervasive Gastrointestinal Diseases Signs and Symptoms, Digestive||Drug: Oralgam (human immunoglobulin)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||June 2006|
- Global improvement in gastrointestinal function
- Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110708
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